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2. European Evidence-based Consensus: Inflammatory Bowel Disease and Malignancies

Author

Annese, Vito, Beaugerie, Laurent, Egan, Laurence, Biancone, Livia, Bolling, Claus, Brandts, Christian, Dierickx, Daan, Dummer, Reinhard, Fiorino, Gionata, Gornet, Jean Marc, Higgins, Peter, Katsanos, Konstantinos H., Nissen, Loes, Pellino, Gianluca, Rogler, Gerhard, Scaldaferri, Franco, Szymanska, Edyta, Eliakim, Rami, Bossuyt, P., Bogut, A., Krznaric, Z., Mijandrusic Sincic, B., Bortlik, M., Douda, T., Knudsen, T., Manninen, P., Nieminen, U., Kucharzik, T., Siegmund, B., Koutroubakis, I., Epameinondas, T., Lakatos, P., Waterman, M., Kohn, A., Goll, Null, Kierkus, J., Zagorowicz, E., Diculescu, M. M., Tarabar, D., Drobne, D., Gisbert, J., Strid, H., Pierik, M., Celik, A. F., Irving, P., Marshall, J., Riis, L., Amiot, A., Mantzaris, G., Sinagra, E., Sampietro, G., D'Incà, R., De Ridder, L., Nunesl, P. B., Marin Jimenez, I., Ramirez, V. H., Juillerat, P., Claridge, A., Macdonald, J., Rieder, F., SELVAGGI, Francesco, University of Zurich, Annese, Vito, Bossuyt, Peter, Beaugerie, Laurent, Egan, Laurence, Biancone, Livia, Bolling, Clau, Brandts, Christian, Dierickx, Daan, Dummer, Reinhard, Fiorino, Gionata, Gornet, Jean Marc, Higgins, Peter, Katsanos, Konstantinos H., Nissen, Loe, Pellino, Gianluca, Rogler, Gerhard, Scaldaferri, Franco, Szymanska, Edyta, Eliakim, Rami, Bossuyt, P., Bogut, A., Krznaric, Z., Mijandrusic Sincic, B., Bortlik, M., Douda, T., Knudsen, T., Manninen, P., Nieminen, U., Kucharzik, T., Siegmund, B., Koutroubakis, I., Epameinondas, T., Lakatos, P., Waterman, M., Kohn, A., Goll, Null, Kierkus, J., Zagorowicz, E., Diculescu, M. M., Tarabar, D., Drobne, D., Gisbert, J., Strid, H., Pierik, M., Celik, A. F., Irving, P., Marshall, J., Riis, L., Amiot, A., Mantzaris, G., Sinagra, E., Selvaggi, Francesco, Sampietro, G., D'Incà, R., De Ridder, L., Nunesl, P. B., Marin Jimenez, I., Ramirez, V. H., Juillerat, P., Claridge, A., Macdonald, J., and Rieder, F.

Subjects
medicine.medical_specialty, Evidence-based practice, Prognosi, Alternative medicine, MEDLINE, 610 Medicine & health, Malignancy, Inflammatory bowel disease, Risk Factors, Neoplasms, medicine, Humans, 2715 Gastroenterology, Settore MED/12 - Gastroenterologia, Evidence-Based Medicine, business.industry, Risk Factor, Medicine (all), Inflammatory Bowel Disease, Gastroenterology, 10177 Dermatology Clinic, Cancer, General Medicine, Evidence-based medicine, Inflammatory Bowel Diseases, Prognosis, medicine.disease, Ulcerative colitis, Europe, 10219 Clinic for Gastroenterology and Hepatology, Family medicine, Immunology, Neoplasm, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human
Abstract

The global prevalence of cancer is increasing, largely as more patients are living into old age. Therefore, gastroenterologists caring for patients with inflammatory bowel disease [IBD] increasingly are managing patients with cancer, or a previous history of cancer. This often requires joint management with the patient’s oncologist, enabling case-by-case decision-making based on the characteristics and expected evolution of the index cancer. Previously, no European guidelines existed describing the impact of IBD on malignancy. For this reason, the European Crohn’s and Colitis Organisation [ECCO] Guidelines Committee [GuiCom] decided to elaborate a set of Consensus Statements on optimal risk/benefit strategies for treating IBD patients with cancer or a history of cancer. The development of clinical practice guidelines is expensive and time consuming, and it is the Committee’s hope that these statements will facilitate and accelerate future efforts to elaborate formal guidelines, providing useful information on areas for which evidence is lacking and where controlled studies are needed. The strategy used to produce the Consensus Statements involved five steps: 1. Two members of Guicom [VA and RE] identified four main topics that needed to be addressed: a] IBD and solid tumours; b] IBD and skin and haematological malignancies; c] malignancy related to therapy: risk and prevention; and d] management of IBD patients with a history of malignancy. During 2014, calls for participation in the drafting of consensus statements were issued to ECCO members, and selected oncologists known for their expertise and active research in the field were invited to join the Consensus. Participants were selected by the Committee, and four working groups were created, each composed of a chairperson [LE, RE, LB, and VA], two ECCO members including young members [Y-ECCO], and one or two experienced oncologists. The chairmen and their groups elaborated relevant questions on topics dealing with current practice and/or areas …

Published
2015

5. 3rd European evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 2: Surgical management and special situations

Author

Gionchetti, P. (Paolo), Dignass, A. (Axel), Danese, S. (Silvio), Dias, F.J.M. (Fernando José Magro), Rogler, G. (Gerhard), Lakatos, P.L. (Péter Laszlo), Adamina, M. (Michel), Ardizzone, S. (Sandro), Buskens, C.J. (Christianne), Sebastian, S. (Shaji), Laureti, S. (Silvio), Sampietro, G.M. (Gianluca M.), Vucelic, B. (B.), Woude, C.J. (Janneke) van der, Manuel Barreiro-de Acosta, (), Maaser, C. (Christian), Portela, F. (Francisco), Vavricka, S.R. (Stephan R.), Gomollón, F. (Fernando), Vito, A. (Annese), Marco, D. (Daperno), Alessandro, A. (Armuzzi), Gionata, F. (Fiorino), Fernando, R. (Rizzello), Silvio, D. (Danese), Sandro, A. (Ardizzone), Paolo, G. (Gionchetti), Gianluca, S. (Sampietro), Silvio, L. (Laureti), Kohn, A. (Anna), Simone, S. (Saibeni), Livia, B. (Biancone), Herbert, T. (Tilg), Garret, C. (Cullen), Colm O'Morain, (), Torsten, K. (Kucharzik), Axel, D. (Dignass), Jost, L. (Langhorst), Christian, M. (Maaser), Sturm, A. (Andreas), Lasitschka, F. (Felix), Florian, R. (Rieder), van Gert, A. (Assche), Bossuyt, P. (Peter), Sven, A. (Almer), Harbord, M. (Marcus), James, L. (Lindsay), Shaji, S. (Sebastian), Irving, P. (Peter), Miquel, S. (Sans), Fernando, G. (Gomollon), Manuel, B.D.A. (Barreiro De Acosta), Jorda, F.C. (Francesc Casellas), Federico, A.A. (Arguelles Arias), Laurent, P.-B. (Peyrin-Biroulet), Carbonnel, F. (Franck), Yehuda, C. (Chowers), Pascal, J. (Juillerat), Michel, A. (Adamina), Gerhard, R. (Rogler), Stephan, V. (Vavricka), Mantzaris Gerassimos, J. (J.), Koutroubakis, I. (Ioannis), Katsanos, K. (Konstantinos), Fernando, M. (Magro), Francisco, P. (Portela), Christianne, B. (Buskens), van der Woude, J. (Janneke), Boris, V. (Vucelic), Mijandrusic-Sincic, B. (Brankica), Peter, L. (Lakatos), Douda, T. (Thomas), Brynskov, J. (Jorn), Knudsen, T. (Torben), Manninen, P. (Pia), Berset, I.P. (Ingrid Prytz), Kierkus, J. (J.), Zagorowicz, E. (Edyta), Diculescu, M.M. (Mihai Mircea), Goldis, A.E. (Adrian Eugen), Potapov, A. (Alexander), Celik, A.F. (Aykut Ferhat), Aldis, P. (Pukitis), Gionchetti, P. (Paolo), Dignass, A. (Axel), Danese, S. (Silvio), Dias, F.J.M. (Fernando José Magro), Rogler, G. (Gerhard), Lakatos, P.L. (Péter Laszlo), Adamina, M. (Michel), Ardizzone, S. (Sandro), Buskens, C.J. (Christianne), Sebastian, S. (Shaji), Laureti, S. (Silvio), Sampietro, G.M. (Gianluca M.), Vucelic, B. (B.), Woude, C.J. (Janneke) van der, Manuel Barreiro-de Acosta, (), Maaser, C. (Christian), Portela, F. (Francisco), Vavricka, S.R. (Stephan R.), Gomollón, F. (Fernando), Vito, A. (Annese), Marco, D. (Daperno), Alessandro, A. (Armuzzi), Gionata, F. (Fiorino), Fernando, R. (Rizzello), Silvio, D. (Danese), Sandro, A. (Ardizzone), Paolo, G. (Gionchetti), Gianluca, S. (Sampietro), Silvio, L. (Laureti), Kohn, A. (Anna), Simone, S. (Saibeni), Livia, B. (Biancone), Herbert, T. (Tilg), Garret, C. (Cullen), Colm O'Morain, (), Torsten, K. (Kucharzik), Axel, D. (Dignass), Jost, L. (Langhorst), Christian, M. (Maaser), Sturm, A. (Andreas), Lasitschka, F. (Felix), Florian, R. (Rieder), van Gert, A. (Assche), Bossuyt, P. (Peter), Sven, A. (Almer), Harbord, M. (Marcus), James, L. (Lindsay), Shaji, S. (Sebastian), Irving, P. (Peter), Miquel, S. (Sans), Fernando, G. (Gomollon), Manuel, B.D.A. (Barreiro De Acosta), Jorda, F.C. (Francesc Casellas), Federico, A.A. (Arguelles Arias), Laurent, P.-B. (Peyrin-Biroulet), Carbonnel, F. (Franck), Yehuda, C. (Chowers), Pascal, J. (Juillerat), Michel, A. (Adamina), Gerhard, R. (Rogler), Stephan, V. (Vavricka), Mantzaris Gerassimos, J. (J.), Koutroubakis, I. (Ioannis), Katsanos, K. (Konstantinos), Fernando, M. (Magro), Francisco, P. (Portela), Christianne, B. (Buskens), van der Woude, J. (Janneke), Boris, V. (Vucelic), Mijandrusic-Sincic, B. (Brankica), Peter, L. (Lakatos), Douda, T. (Thomas), Brynskov, J. (Jorn), Knudsen, T. (Torben), Manninen, P. (Pia), Berset, I.P. (Ingrid Prytz), Kierkus, J. (J.), Zagorowicz, E. (Edyta), Diculescu, M.M. (Mihai Mircea), Goldis, A.E. (Adrian Eugen), Potapov, A. (Alexander), Celik, A.F. (Aykut Ferhat), and Aldis, P. (Pukitis)

Abstract

This paper is the second in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn's disease [CD] and concerns the surgical management of CD as well as special situations including management of perianal CD and extraintestinal manifestations. Diagnostic approaches and medical management of CD of this ECCO Consensus are covered in the first paper [Gomollon et al. JCC 2016].

Published
2017
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6. 3rd European evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management

Author

Gomollon, F., Dignass, A., Annese, V., Tilg, H., Van Assche, G., Lindsay, J. O., Peyrin-Biroulet, L., Cullen, G. J., Daperno, M., Kucharzik, T., Rieder, F., Almer, S., Armuzzi, Alessandro, Harbord, M., Langhorst, J., Sans, M., Chowers, Y., Fiorino, G., Juillerat, P., Mantzaris, G. J., Rizzello, F., Vavricka, S., Gionchetti, P., Bossuyt, P., Mijandrusic-Sincic, B., Douda, T., Brynskov, J., Knudsen, T., Manninen, P., Carbonnel, F., Sturm, A., Koutroubakis, I., O'Morain, C., Kohn, A., Berset, I. P., Kierkus, J., Zagorowicz, E., Diculescu, M. M., Goldis, A., Potapov, A., Jorda, F. C., Celik, A. F., Irving, P., Armuzzi A. (ORCID:0000-0003-1572-0118), Gomollon, F., Dignass, A., Annese, V., Tilg, H., Van Assche, G., Lindsay, J. O., Peyrin-Biroulet, L., Cullen, G. J., Daperno, M., Kucharzik, T., Rieder, F., Almer, S., Armuzzi, Alessandro, Harbord, M., Langhorst, J., Sans, M., Chowers, Y., Fiorino, G., Juillerat, P., Mantzaris, G. J., Rizzello, F., Vavricka, S., Gionchetti, P., Bossuyt, P., Mijandrusic-Sincic, B., Douda, T., Brynskov, J., Knudsen, T., Manninen, P., Carbonnel, F., Sturm, A., Koutroubakis, I., O'Morain, C., Kohn, A., Berset, I. P., Kierkus, J., Zagorowicz, E., Diculescu, M. M., Goldis, A., Potapov, A., Jorda, F. C., Celik, A. F., Irving, P., and Armuzzi A. (ORCID:0000-0003-1572-0118)

Abstract

This paper is the first in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn's disease and concerns the methodology of the consensus process, and the classification, diagnosis and medical management of active and quiescent Crohn's disease. Surgical management as well as special situations including management of perianal Crohn's disease of this ECCO Consensus are covered in a subsequent second paper [Gionchetti et al JCC 2016].

Published
2017

8. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease

Author

Ruemmele, F, Veres, G, Kolho, K, Griffiths, A, Levine, A, Escher, J, Amil Dias, J, Barabino, A, Braegger, C, Bronsky, J, Buderus, S, Martín-de-Carpi, J, De Ridder, L, Fagerberg, U, Hugot, J, Kierkus, J, Kolacek, S, Koletzko, S, Lionetti, P, Miele, E, Navas López, V, Paerregaard, A, Russell, R, Serban, D, Shaoul, R, Van Rheenen, P, Veereman, G, Weiss, B, Wilson, D, Dignass, A, Eliakim, A, Winter, H, Turner, D, Novacek, G, Bossuyt, P, Douda, T, Knudsen, T, Carbonnel, F, Sturm, A, Koutroubakis, I, Lakatos, P, Gionchetti, P, Pierik, M, Prytz-Berset, I, Zagorowicz, E, Magro, F, Potapov, A, Gomollón, F, Strid, H, Irving, P, Shamir, R, Vandenplas, Y, Gottrand, F, Papadopoulou, A, Wilschanski, M, Orel, R, Schaeppi, M, Falconer, J, Heuschkel, R, Karkelis, S, Thapar, N, Baumann, U, Koletzko, B, D'Antiga, L, Troncone, R, Benninga, M, Mearin, L, Phillips, A, Diculescu, M, Ruemmele, FM, Kolho, KL, Escher, JC, Braegger, CP, Fagerberg, UL, Hugot, JP, Navas López, VM, Russell, RK, Serban, DE, Diculescu, MM, Ruemmele, F, Veres, G, Kolho, K, Griffiths, A, Levine, A, Escher, J, Amil Dias, J, Barabino, A, Braegger, C, Bronsky, J, Buderus, S, Martín-de-Carpi, J, De Ridder, L, Fagerberg, U, Hugot, J, Kierkus, J, Kolacek, S, Koletzko, S, Lionetti, P, Miele, E, Navas López, V, Paerregaard, A, Russell, R, Serban, D, Shaoul, R, Van Rheenen, P, Veereman, G, Weiss, B, Wilson, D, Dignass, A, Eliakim, A, Winter, H, Turner, D, Novacek, G, Bossuyt, P, Douda, T, Knudsen, T, Carbonnel, F, Sturm, A, Koutroubakis, I, Lakatos, P, Gionchetti, P, Pierik, M, Prytz-Berset, I, Zagorowicz, E, Magro, F, Potapov, A, Gomollón, F, Strid, H, Irving, P, Shamir, R, Vandenplas, Y, Gottrand, F, Papadopoulou, A, Wilschanski, M, Orel, R, Schaeppi, M, Falconer, J, Heuschkel, R, Karkelis, S, Thapar, N, Baumann, U, Koletzko, B, D'Antiga, L, Troncone, R, Benninga, M, Mearin, L, Phillips, A, Diculescu, M, Ruemmele, FM, Kolho, KL, Escher, JC, Braegger, CP, Fagerberg, UL, Hugot, JP, Navas López, VM, Russell, RK, Serban, DE, and Diculescu, MM

Abstract

Children and adolescents with Crohn's disease (CD) present often with a more complicated disease course compared to adult patients. In addition, the potential impact of CD on growth, pubertal and emotional development of patients underlines the need for a specific management strategy of pediatric-onset CD. To develop the first evidenced based and consensus driven guidelines for pediatric-onset CD an expert panel of 33 IBD specialists was formed after an open call within the European Crohn's and Colitis Organisation and the European Society of Pediatric Gastroenterolog, Hepatology and Nutrition. The aim was to base on a thorough review of existing evidence a state of the art guidance on the medical treatment and long term management of children and adolescents with CD, with individualized treatment algorithms based on a benefit-risk analysis according to different clinical scenarios. In children and adolescents who did not have finished their growth, exclusive enteral nutrition (EEN) is the induction therapy of first choice due to its excellent safety profile, preferable over corticosteroids, which are equipotential to induce remission. The majority of patients with pediatric-onset CD require immunomodulator based maintenance therapy. The experts discuss several factors potentially predictive for poor disease outcome (such as severe perianal fistulizing disease, severe stricturing/penetrating disease, severe growth retardation, panenteric disease, persistent severe disease despite adequate induction therapy), which may incite to an anti-TNF-based top down approach. These guidelines are intended to give practical (whenever possible evidence-based) answers to (pediatric) gastroenterologists who take care of children and adolescents with CD; they are not meant to be a rule or legal standard, since many different clinical scenario exist requiring treatment strategies not covered by or different from these guidelines.

Published
2014

9. Significant decrease in prevalence of Helicobacter pylori in the Czech Republic

Author

Bureš, J., Kopáčová, M., Koupil, Ilona, Seifert, B., Škodová Fendrichová, M., Špirková, J., Voříšek, V., Rejchrt, S., Douda, T., Král, N., Tachecí, I., Bureš, J., Kopáčová, M., Koupil, Ilona, Seifert, B., Škodová Fendrichová, M., Špirková, J., Voříšek, V., Rejchrt, S., Douda, T., Král, N., and Tachecí, I.

Abstract

METHODS: A total of 22 centres entered the study. The catchment areas of these centres covered cities and towns with more than 20 000 inhabitants, smaller towns (<= 20 000 inhabitants) with surrounding villages and rural areas, and were spread over the whole country, corresponding well to the geographical distribution of the Czech population. A total of 1 837 subjects (aged 5-98 years) took part in the study, randomly selected out of 38 147 people from the general population. H. pylori infection was investigated by means of a C-13-urea breath test. Breath samples in duplicates were analysed using isotope ratio mass spectrometry. The cut-off point was 3.5. Social and demographic characteristics were based on data from self-completed questionnaires. RESULTS: The overall prevalence of H. pylori infection was 23.5% (430/1826), and 4.8% (20/420) in children aged 15 or less. There was no statistically significant difference in prevalence between males (24.3%; 208/857) and females (22.9%, 222/969, P = 0.494). H. pylon infection was strongly associated with higher age, among subjects aged 55+ years, prevalence of H. pylori infection was 39.8% (252/633, P < 0.001). The highest prevalence of H. pylori infection was found among persons aged 55-64 years (43.9%, 97/221) and 75+ years (37.9%, 58/153). Among study subjects aged 15+ years, prevalence of H. pylori infection was significantly increased in those with lowest education (odds risk 3.19, 95% CI 1.87-5.47). Compared to never married (14.1%), the prevalence of H. pylori infection was statistically significantly higher among married (35.4%, 246/694, P < 0.001), divorced (36.8%, 49/133, P < 0.001) and widowed study subjects (40.2%, 45/112, P < 0.001), both in minimally and fully adjusted analysis. There was no significant difference in the prevalence of H. pylori infection between married and widowed subjects (35.4%, 246/694 vs 40.2%, 45/112, P = 0.389). There was little variation in smoking prevalence across c, Ilona Koupil was involved in a collaborative study of Helicobacter pylori with researchers from Charles University in Prague. The research group have now published results from two large multi-centre studies completed in 2001 and 2011 and showed a substantial decrease in the overall prevalence of H. pylori infection in the general population in the Czech Republic over the past 10 years. This decrease is interpreted as a result of the relatively favourable and improving socio-economic conditions. Despite the overall decrease in prevalence of H. pylori, there are persisting inequalities between educational groups within the country.

Published
2012
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13. Epidemiology of Helicobacter pylori infection in the Czech Republic

Author

Bures, J., Kopacova, M., Koupil, I., Vorisek, V., Rejchrt, S., Beranek, M., Seifert, B., Pozler, O., Zivny, P., Douda, T., Kolesarova, M., Pinter, M., Palicka, V., Holcik, J., the European Society for Primary Care Gastroenterology, and, Bures, J., Kopacova, M., Koupil, I., Vorisek, V., Rejchrt, S., Beranek, M., Seifert, B., Pozler, O., Zivny, P., Douda, T., Kolesarova, M., Pinter, M., Palicka, V., Holcik, J., and the European Society for Primary Care Gastroenterology, and

Published
2006

14. Social determinants of Helicobacter Pylori infection: Czech Republic in the context of Europe [abstract]

Author

Bures, J., Kopacova, M., Koupil, I., Vorisek, V., Rejchrt, S., Beranek, M., Seifert, B., Pozler, O., Zivny, P., Douda, T., Kolesarova, M., Pinter, M., Palicka, V., Holcik, J., the European Society for Primary Care Gastroenterology, and, Bures, J., Kopacova, M., Koupil, I., Vorisek, V., Rejchrt, S., Beranek, M., Seifert, B., Pozler, O., Zivny, P., Douda, T., Kolesarova, M., Pinter, M., Palicka, V., Holcik, J., and the European Society for Primary Care Gastroenterology, and

Published
2005

19. Comparison of different protocols for 13 C‐urea breath test for the diagnosis of Helicobacter pylori infection in healthy volunteers.

Author

Kopáčová, M., Bureš, J., VořÍšek, V., Konštacký, M., Rejchrt, S., Živný, P., Douda, T., and Palička, V.

Subjects
HELICOBACTER pylori, HELICOBACTER diseases, CITRUS fruits, MASS spectrometry, SPECTRUM analysis, INTERFEROMETRY
Abstract

Objective . The 13 C‐urea breath test ( 13 C‐UBT) is the most accurate non‐invasive method for diagnosis of Helicobacter pylori infection. However, several methodological issues have not been resolved yet. The aim of this study was to test different protocols of 13 C‐UBT to find the optimal test drink and sampling interval. Material and methods . 13 C‐UBT was performed at 3‐day intervals in 27 healthy volunteers using citric acid (test A), orange juice (B) and still water (C) as test drinks. Breath samples were collected from time 5 to 60 min. A total number of 2106 breath samples were analysed by isotope ratio mass spectrometry (cut‐off value 3.5). Results . Differences in delta values were greater than would be expected by chance (A versus B and A versus C at times 20, 25, 30, 35 and 40 min, p [ABSTRACT FROM AUTHOR]

Published
2005
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20. Combination therapy with interferon alpha-2b and ribavirin of patients with chronic hepatitis C - Results of Czech multicentre trial | Kombinovaná terapie interferonem alfa-2b a ribavirinem nemocných s chronickou hepatitidou C - Výsledky České multicentrické studie

Author

Husa, P., Krtek, V., Švejda, J., Stránský, J., Cieslarová, B., Nádvorník, V., Ehrmann, J., Urbánek, P., Volfová, M., Svobodník, A., Březoviáková, J., Přibylová, I., Strakrle, V., Zdvořák, J., Kümpel, P., Průchová, M., Pokorná, B., Nedvědová, L., Fryšák, Z., Ondráček, P., Hájek, J., Plíšek, S., Kapla, J., Douda, T., Kordas, M., Janků, J., Gabalec, L., Rožnovský, L., Slesinger, P., Pavel Chalupa, Krekulová, L., Ďurovič, I., Skála, J., Cee, J., Pulgretová, D., Záleská, K., Wohl, P., Krkoška, A., Čermák, O., Votoček, S., and Měšt Ánková, O.

27. Combination therapy with interferon alpha-2b and ribavirin of patients with chronic hepatitis C - Results of Czech multicentre trial,Kombinovaná terapie interferonem alfa-2b a ribavirinem nemocných s chronickou hepatitidou C - Výsledky České multicentrické studie

Author

Petr Husa, Krtek, V., Švejda, J., Stránský, J., Cieslarová, B., Nádvorník, V., Ehrmann, J., Urbánek, P., Volfová, M., Svobodník, A., Březoviáková, J., Přibylová, I., Strakrle, V., Zdvořák, J., Kümpel, P., Průchová, M., Pokorná, B., Nedvědová, L., Fryšák, Z., Ondráček, P., Hájek, J., Plíšek, S., Kapla, J., Douda, T., Kordas, M., Janků, J., Gabalec, L., Rožnovský, L., Slesinger, P., Chalupa, P., Krekulová, L., Ďurovič, I., Skála, J., Cee, J., Pulgretová, D., Záleská, K., Wohl, P., Krkoška, A., Čermák, O., Votoček, S., and Měšt Ánková, O.

29. Guidelines for the administration of biological therapy in patients with inflammatory bowel diseases: 2 nd edition | Doporučení pro podávání biologické terapie u idiopatických střevních zánětů: 2. vydání

Author

Bortlík, M., Ďuricová, D., Kohout, P., Konečný, M., Koželuhová, J., Ales Novotny, Zbořil, V., Prokopová, L., Douda, T., Stehlík, J., Shonová, O., Mareš, K., Hrdlička, L., Matějková, P., Šerclová, Z., Nedbalová, L., Tomanová, M., Liberda, M., Bronský, J., Mitrová, K., Drastich, P., and Lukáš, M.

42. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study

Author

Silvio Danese, Jean-Frederic Colombel, Milan Lukas, Javier P Gisbert, Geert D'Haens, Bu'hussain Hayee, Remo Panaccione, Hyun-Soo Kim, Walter Reinisch, Helen Tyrrell, Young S Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Meina Tao Tang, Stefan Schreiber, Nazimuddin Aboo, Tariq Ahmad, Xavier Aldeguer Mante, Matthieu Allez, Sven Almer, Romain Altwegg, Montserrat Andreu Garcia, Ramesh Arasaradnam, Sandro Ardizzone, Alessandro Armuzzi, Ian Arnott, Guy Aumais, Irit Avni-Biron, Peter Barrow, Ian Beales, Fernando Bermejo San Jose, Abraham Bezuidenhout, Livia Biancone, Michael Blaeker, Stuart Bloom, Bernd Bokemeyer, Fabrizio Bossa, Peter Bossuyt, Guillaume Bouguen, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Arnaud Bourreille, Christian Boustiere, Tomas Brabec, Stephan Brand, Carsten Buening, Anthony Buisson, Guillaume Cadiot, Xavier Calvet Calvo, Franck Carbonnel, Daniel Carpio, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Nicoleta-Claudia Cimpoeru, Martin Clodi, Gino Roberto Corazza, Rocco Cosintino, Jose Cotter, Thomas Creed, Fraser Cummings, Gian Luigi de' Angelis, Marc De Maeyer, Milind Desai, Etienne Desilets, Pierre Desreumaux, Olivier Dewit, Johanna Dinter, Ecaterina Daniela Dobru, Tomas Douda, Dan Lucian Dumitrascu, Matthias Ebert, Ana Echarri Piudo, Magdy Elkhashab, Chang Soo Eun, Brian Feagan, Roland Fejes, Catarina Fidalgo, Sigal Fishman, Bernard Flourié, Sharyle Fowler, Walter Fries, Csaba Fulop, Mathurin Fumery, Gyula G Kiss, Sonja Gassner, Daniel Gaya, Bastianello Germanà, Liliana Simona Gheorghe, Cyrielle Gilletta de Saint Joseph, Paolo Gionchetti, Adrian-Eugen Goldis, Raquel Gonçalves, Jean-Charles Grimaud, Tibor Gyökeres, Herve Hagege, Andrei Haidar, Heinz Hartmann, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Per Hellström, Pieter Hindryckx, Helena Hlavova, Frank Hoentjen, Stefanie Howaldt, Ludek Hrdlicka, Kyu Chan Huh, Maria Isabel Iborra Colomino, Florentina Ionita-Radu, Peter Irving, Jørgen Jahnsen, ByungIk Jang, Jeroen Jansen, Seong Woo Jeon, Rodrigo Jover Martinez, Pascal Juillerat, Per Karlén, Arthur Kaser, Radan Keil, Deepak Kejariwal, Dan Keret, Reena Khanna, Dongwoo Kim, Duk Hwan Kim, Hyo-Jong Kim, Joo Sung Kim, Kueongok Kim, Kyung-Jo Kim, Sung Kook Kim, Young-Ho Kim, Jochen Klaus, Anna Kohn, Vladimir Kojecky, Ja Seol Koo, Robert Kozak, Milan Kremer, Tunde Kristof, Frederik Kruger, David Laharie, Adi Lahat-zok, Evgeny Landa, Jonghun Lee, Kang-Moon Lee, Kook Lae Lee, YooJin Lee, Frank Lenze, Wee Chian Lim, Jimmy Limdi, James Lindsay, Pilar Lopez Serrano, Edouard Louis, Stefan Lueth, Giovanni Maconi, Fazia Mana, Steven Mann, John Mansfield, Santino Marchi, Marco Marino, John Marshall, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, John McLaughlin, Simon McLaughlin, Ehud Melzer, Jessica Mertens, Paul Mitrut, Tamas Molnar, Vinciane Muls, Pushpakaran Munuswamy, Charles Murray, Timna Naftali, Visvakuren Naidoo, Yusuf Nanabhay, Lucian Negreanu, Augustin Nguyen, Thomas Ochsenkuehn, Ambrogio Orlando, Julian Panes Diaz, Maya Paritsky, Dong Il Park, Jihye Park, Luca Pastorelli, Markus Peck-Radosavljevic, Farhad Peerani, Javier Perez Gisbert, Laurent Peyrin-Biroulet, Laurence Picon, Marieke Pierik, Terry Ponich, Francisco Portela, Maartens Jeroen Prins, Istvan Racz, Khan Fareed Rahman, Jean-Marie Reimund, Max Reinshagen, Xavier Roblin, Rodolfo Rocca, Francesca Rogai, Gerhard Rogler, Agnes Salamon, Ennaliza Salazar, Zoltan Sallo, Sunil Samuel, Miquel de los Santos Sans Cuffi, Edoardo Vincenzo Savarino, Vincenzo Savarino, Guillaume Savoye, Andrada Seicean, Christian Selinger, David Martins Serra, Hang Hock Shim, SungJae Shin, Britta Siegmund, Jesse Siffledeen, Wayne Simmonds, Jan Smid, Jose Sollano, Geun Am Song, Alexander Speight, Ioan Sporea, Dirk Staessen, George Stancu, Alan Steel, David Stepek, Victor Stoica, Andreas Sturm, Gyorgy Szekely, Teck Kiang Tan, Carlos Taxonera Samso, John Thomson, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Marcello Vangeli, Marta Varga, Ana Vieira, Stephanie Viennot, Erica Villa, Petr Vitek, Harald Vogelsang, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Byong Duk Ye, Christopher Ziady, Danese S., Colombel J.-F., Lukas M., Gisbert J.P., D'Haens G., Hayee B., Panaccione R., Kim H.-S., Reinisch W., Tyrrell H., Oh Y.S., Tole S., Chai A., Chamberlain-James K., Tang M.T., Schreiber S., Aboo N., Ahmad T., Aldeguer Mante X., Allez M., Almer S., Altwegg R., Andreu Garcia M., Arasaradnam R., Ardizzone S., Armuzzi A., Arnott I., Aumais G., Avni-Biron I., Barrow P., Beales I., Bermejo San Jose F., Bezuidenhout A., Biancone L., Blaeker M., Bloom S., Bokemeyer B., Bossa F., Bossuyt P., Bouguen G., Bouhnik Y., Bouma G., Bourdages R., Bourreille A., Boustiere C., Brabec T., Brand S., Buening C., Buisson A., Cadiot G., Calvet Calvo X., Carbonnel F., Carpio D., Cheon J.H., Chiba N., Chioncel C., Cimpoeru N.-C., Clodi M., Corazza G.R., Cosintino R., Cotter J., Creed T., Cummings F., de' Angelis G.L., De Maeyer M., Desai M., Desilets E., Desreumaux P., Dewit O., Dinter J., Dobru E.D., Douda T., Dumitrascu D.L., Ebert M., Echarri Piudo A., Elkhashab M., Eun C.S., Feagan B., Fejes R., Fidalgo C., Fishman S., Flourie B., Fowler S., Fries W., Fulop C., Fumery M., G Kiss G., Gassner S., Gaya D., Germana B., Gheorghe L.S., Gilletta de Saint Joseph C., Gionchetti P., Goldis A.-E., Goncalves R., Grimaud J.-C., Gyokeres T., Hagege H., Haidar A., Hartmann H., Hasselblatt P., Hebuterne X., Hellstrom P., Hindryckx P., Hlavova H., Hoentjen F., Howaldt S., Hrdlicka L., Huh K.C., Iborra Colomino M.I., Ionita-Radu F., Irving P., Jahnsen J., Jang B., Jansen J., Jeon S.W., Jover Martinez R., Juillerat P., Karlen P., Kaser A., Keil R., Kejariwal D., Keret D., Khanna R., Kim D., Kim D.H., Kim H.-J., Kim J.S., Kim K., Kim K.-J., Kim S.K., Kim Y.-H., Klaus J., Kohn A., Kojecky V., Koo J.S., Kozak R., Kremer M., Kristof T., Kruger F., Laharie D., Lahat-zok A., Landa E., Lee J., Lee K.-M., Lee K.L., Lee Y., Lenze F., Lim W.C., Limdi J., Lindsay J., Lopez Serrano P., Louis E., Lueth S., Maconi G., Mana F., Mann S., Mansfield J., Marchi S., Marino M., Marshall J., Martin Arranz M.D., Mateescu R.-B., McLaughlin J., McLaughlin S., Melzer E., Mertens J., Mitrut P., Molnar T., Muls V., Munuswamy P., Murray C., Naftali T., Naidoo V., Nanabhay Y., Negreanu L., Nguyen A., Ochsenkuehn T., Orlando A., Panes Diaz J., Paritsky M., Park D.I., Park J., Pastorelli L., Peck-Radosavljevic M., Peerani F., Perez Gisbert J., Peyrin-Biroulet L., Picon L., Pierik M., Ponich T., Portela F., Prins M.J., Racz I., Rahman K.F., Reimund J.-M., Reinshagen M., Roblin X., Rocca R., Rogai F., Rogler G., Salamon A., Salazar E., Sallo Z., Samuel S., Sans Cuffi M.D.L.S., Savarino E.V., Savarino V., Savoye G., Seicean A., Selinger C., Serra D.M., Shim H.H., Shin S., Siegmund B., Siffledeen J., Simmonds W., Smid J., Sollano J., Song G.A., Speight A., Sporea I., Staessen D., Stancu G., Steel A., Stepek D., Stoica V., Sturm A., Szekely G., Tan T.K., Taxonera Samso C., Thomson J., Tichy M., Toth G.T., Tulassay Z., Vangeli M., Varga M., Vieira A., Viennot S., Villa E., Vitek P., Vogelsang H., Vyhnalek P., Wahab P., Walldorf J., Ye B.D., and Ziady C.

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Population, Antibodies, Monoclonal, Humanized, Injections, Subcutaneou, Placebo, Severity of Illness Index, Gastroenterology, Young Adult, Double-Blind Method, Internal medicine, Gastrointestinal Agent, Clinical endpoint, medicine, education, Adverse effect, Aged, Aged, 80 and over, education.field_of_study, Hepatology, business.industry, Middle Aged, medicine.disease, Ulcerative colitis, Infliximab, Treatment Outcome, Etrolizumab, Concomitant, Colitis, Ulcerative, Female, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human, medicine.drug
Abstract

Item does not contain fulltext BACKGROUND: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS: We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS: Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION: To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING: F Hoffmann-La Roche.

Published
2022

43. Mucosal healing is not associated with better outcome during 7 years of follow-up in pediatric patients with Crohn's disease.

Author

Melek J, Štanclová M, Dědek P, Štichhauer R, Koudelka J, Douda T, Tachecí I, Douda L, Vaňásek T, and Bureš J

Subjects
Humans, Male, Female, Retrospective Studies, Child, Adolescent, Follow-Up Studies, Treatment Outcome, Wound Healing, Tertiary Care Centers, Time Factors, Infliximab therapeutic use, Crohn Disease therapy, Hospitalization statistics & numerical data, Intestinal Mucosa pathology
Abstract

Background: Mucosal healing (MH) has become a perspective treatment target in patients with Crohn's disease (CD). Data about the impact of MH on long-term outcome in pediatric patients are still scarce., Methods: Seventy-six pediatric patients with CD were evaluated retrospectively (2000-2015) in a tertiary care center. Based on MH achievement, they were divided into two groups (MH, N.=17; and No MH, N.=59). The primary endpoint was to assess the association of MH and the need for CD-related hospitalizations or surgery in pediatric patients with CD., Results: The number of hospitalized patients was 24% in the MH group and 42% in the No MH group (P=0.26). The total number of CD-related hospitalizations was not significant between the MH group and the No MH group (5 vs. 41, P=0.15). The time to the first hospitalization was 24 months in MH and 21 months in No MH (P>0.99). About 24% of the patients in the MH group and 39% patients in the No MH group underwent CD-related operation (P=0.39). Time to the first operation was 43 months for MH and 19 months for the No MH group (P=0.13). The follow-up period was 91 months in the MH group and 80 months in the No MH group (P=0.74). The use of infliximab was positively associated with MH (P=0.002)., Conclusions: MH was not associated with fewer CD-related hospitalizations or operations in pediatric patients with CD during seven years of follow-up.

Published
2024
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44. Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study.

Author

Mitrova K, Pipek B, Bortlik M, Bouchner L, Brezina J, Douda T, Drasar T, Klvana P, Kohout P, Leksa V, Minarikova P, Novotny A, Svoboda P, Skorpik J, Ulbrych J, Veinfurt M, Zborilova B, Lukas M, and Duricova D

Subjects
Female, Humans, Infant, Infant, Newborn, Pregnancy, Placenta, Pregnancy Outcome, Prospective Studies, Treatment Outcome, Tumor Necrosis Factor Inhibitors adverse effects, Tumor Necrosis Factor Inhibitors therapeutic use, Gastrointestinal Agents adverse effects, Gastrointestinal Agents therapeutic use, Maternal Exposure, Inflammatory Bowel Diseases drug therapy, Ustekinumab adverse effects, Ustekinumab therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use
Abstract

Background and Aims: Evidence on the safety of newer biologics during pregnancy is limited. We aimed to assess the safety of ustekinumab and vedolizumab treatment during gestation on pregnancy and infant outcome. Furthermore, we evaluated the placental transfer of these agents., Methods: We performed a prospective, multicentre, observational study in consecutive women with inflammatory bowel disease exposed to ustekinumab or vedolizumab 2 months prior to conception or during pregnancy. Pregnancy, neonatal, and infant outcomes were evaluated and compared with the anti-tumour necrosis factor [TNF]-exposed control group. Drug levels were assessed in maternal and cord blood at delivery., Results: We included 54 and 39 pregnancies exposed to ustekinumab and vedolizumab, respectively. In the ustekinumab group, 43 [79.9%] resulted in live births, and 11 [20.4%] led to spontaneous abortion. Thirty-five [89.7%] pregnancies on vedolizumab ended in a live birth, two [5.1%] in spontaneous, and two [5.1%] in therapeutic abortion. No significant difference in pregnancy outcome between either the vedolizumab or the ustekinumab group and controls was observed [p >0.05]. Similarly, there was no negative safety signal in the postnatal outcome of exposed children regarding growth, psychomotor development, and risk of allergy/atopy or infectious complications. The median infant-to-maternal ratio of ustekinumab levels was 1.67 and it was 0.59 in vedolizumab., Conclusions: Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favuorable pregnancy and postnatal infant outcomes. Placental transfer differed between these two drugs, with ustekinumab having similar and vedolizumab having inverse infant-to-maternal ratio of drug levels compared with anti-TNF preparations., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2022
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45. Serum Citrulline and Ornithine: Potential Markers of Coeliac Disease Activity.

Author

Douda L, Hyšpler R, Mžik M, Vokurková D, Drahošová M, Řeháček V, Čermáková E, Douda T, Cyrany J, Fejfar T, Jirkovský V, Kopáčová M, Kupková B, Vašátko T, Tachecí I, and Bureš J

Subjects
Male, Humans, Female, Adult, Middle Aged, Aged, Ornithine metabolism, Diet, Citrulline metabolism, Celiac Disease
Abstract

Introduction: To date, there is not generally accepted and universal indicator of activity, and functional integrity of the small intestine in patients with coeliac disease. The aim of our study was to investigate whether serum concentrations of the non-essential amino acids citrulline and ornithine might have this function., Methods: We examined serum citrulline and ornithine concentrations in a subgroup of patients with proven coeliac disease and healthy controls (blood donors)., Results: A total of 94 patients with coeliac disease (29 men, mean age 53 ± 18 years; 65 women, mean age 44 ± 14 years) and 35 healthy controls (blood donors) in whom coeliac disease was serologically excluded (10 men, mean age 51 ± 14 years; 25 women, mean age 46 ± 12 years) were included in the study. Significantly lower concentrations of serum ornithine were found in patients with coeliac disease (mean 65 ± 3 μmol/L; median 63 μmol/L, IQR 34 μmol/L, p < 0.001). No statistically nor clinically significant differences were found in the citrulline concentrations between the study and control group., Conclusions: Serum ornithine (but not citrulline) may be useful for assessing the functional status of the small intestine in uncomplicated coeliac disease. Further studies involving more detailed analysis of dietary and metabolic changes in patients will be needed to reach definitive conclusions.

Published
2022
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46. Differences in the placental pharmacokinetics of vedolizumab and ustekinumab during pregnancy in women with inflammatory bowel disease: a prospective multicentre study.

Author

Mitrova K, Pipek B, Bortlik M, Bouchner L, Brezina J, Douda T, Drasar T, Drastich P, Falt P, Klvana P, Leksa V, Novotny A, Svoboda P, Skorpik J, Ulbrych J, Veinfurt M, Zborilova B, Lukas M, and Duricova D

Abstract

Background: Vedolizumab demonstrated different placental pharmacokinetics than other immunoglobulin G1 antibodies, leading to lower drug levels in cord blood in contrast to maternal blood at the time of delivery. The placental transfer of ustekinumab seems to have a pattern similar to anti-tumour necrosis factor agents. Current evidence on the placental pharmacokinetics of vedolizumab and ustekinumab is limited. We aimed to assess the placental transfer of ustekinumab and vedolizumab in pregnant patients with inflammatory bowel disease., Methods: Consecutive women from a prospective observational study who were exposed to ustekinumab or vedolizumab within 2 months prior to conception or during pregnancy were included. Ustekinumab and vedolizumab levels were measured in maternal and cord blood at the time of delivery., Results: Drug levels were available in 31 infant-mother pairs (15 exposed to ustekinumab and 16 to vedolizumab). The median maternal and newborn ustekinumab levels were 5.3 mg/l and 10.3 mg/l, respectively (the median infant-to-maternal ratio was 1.7), while the median maternal and cord vedolizumab levels were 7.3 mg/l and 4.5 mg/l (the median infant-to-maternal ratio was 0.66). The ustekinumab levels in cord blood positively correlated with the maternal levels at delivery (ρ = 0.751, p  = 0.001). However, no correlation with the timing of the last drug administration was found. In contrast, the vedolizumab levels in cord blood demonstrated significant positive correlation with the maternal levels (ρ = 0.831, p  < 0.001) along with the gestational week of the last infusion (ρ = 0.736, p  = 0.001)., Conclusion: Vedolizumab demonstrated different placental pharmacokinetics, leading to lower drug levels in cord blood compared to maternal blood at delivery; in contrast, the placental transfer of ustekinumab seems to have a pattern similar to anti-tumour necrosis factor (TNF) agents., Competing Interests: Conflict of interest statement: Katarina Mitrova: Lectures/congress fees/consultancy (outside the submitted work): Abbvie, Takeda Barbora Pipek: Pfizer Martin Bortlik: Abbvie, Jansen, Pfizer, Takeda, Biogen, Egis Pavel Drastich: Takeda Milan Lukas: Janssen, MSD, Pfizer, Takeda, Egis Dana Duricova: Lectures/congress fees/consultancy (outside the submitted work): Takeda, Jansen, Pfizer Ludek Bouchner, Jan Brezina, Tomas Douda, Tomas Drasar, Premysl Falt, Pavel Klvana, Vaclav Leksa, Ales Novotny, Pavel Svoboda, Jan Skorpik, Jan Ulbrych, Marek Veinfurt, Blanka Zborilova: No disclosure, (© The Author(s), 2021.)

Published
2021
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47. The Effect of Lactobacillus casei on Experimental Porcine Inflammatory Bowel Disease Induced by Dextran Sodium Sulphate.

Author

Bureš J, Kohoutová D, Květina J, Radochová V, Pavlík M, Tichý A, Rejchrt S, Kopáčová M, Douda T, Vysloužil D, and Pejchal J

Subjects
Animals, Dextrans, Disease Models, Animal, Female, Inflammatory Bowel Diseases chemically induced, Sulfates, Swine, Inflammatory Bowel Diseases therapy, Lacticaseibacillus casei, Probiotics pharmacology
Abstract

Background: Gastrointestinal injury caused by dextran sodium sulphate (DSS) is a reliable porcine experimental model of inflammatory bowel disease (IBD). The purpose of this study was to evaluate the effect of probiotic Lactobacillus casei DN 114001 (LC) on DSS-induced experimental IBD., Results: Eighteen female pigs (Sus scrofa f. domestica, weight 33-36 kg, age 4-5 months) were divided into 3 groups (6 animals per group): controls with no treatment, DSS, and DSS + LC. LC was administered to overnight fasting animals in a dietary bolus in the morning on days 1-7 (4.5 × 1010 live bacteria/day). DSS was applied simultaneously on days 3-7 (0.25 g/kg/day). On day 8, the pigs were sacrificed. Histopathological score and length of crypts/glands (stomach, jejunum, ileum, transverse colon), length and width of villi (jejunum, ileum), and mitotic and apoptotic indices (jejunum, ileum, transverse colon) were assessed. DSS increased the length of glands in the stomach, length of crypts and villi in the jejunum and ileum, and the histopathological score of gastrointestinal damage, length of crypts and mitotic activity in the transverse colon. Other changes did not achieve any statistical significance. Administration of LC reduced the length of villi in the jejunum and ileum to control levels and decreased the length of crypts in the jejunum., Conclusions: Treatment with a probiotic strain of LC significantly accelerated regeneration of the small intestine in a DSS-induced experimental porcine model of IBD.

Published
2021
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48. The pharmacokinetic parameters and the effect of a single and repeated doses of memantine on gastric myoelectric activity in experimental pigs.

Author

Bures J, Kvetina J, Radochova V, Tacheci I, Peterova E, Herman D, Dolezal R, Kopacova M, Rejchrt S, Douda T, Sestak V, Douda L, and Karasova JZ

Subjects
Administration, Oral, Alzheimer Disease drug therapy, Animals, Disease Models, Animal, Electromyography, Excitatory Amino Acid Antagonists administration & dosage, Female, Gastrointestinal Diseases diagnosis, Gastrointestinal Diseases physiopathology, Gastrointestinal Motility physiology, Humans, Memantine administration & dosage, Stomach physiopathology, Sus scrofa, Excitatory Amino Acid Antagonists adverse effects, Gastrointestinal Diseases chemically induced, Gastrointestinal Motility drug effects, Memantine adverse effects, Stomach drug effects
Abstract

Background: Memantine, currently available for the treatment of Alzheimer's disease, is an uncompetitive antagonist of the N-methyl-D-aspartate type of glutamate receptors. Under normal physiologic conditions, these unstimulated receptor ion channels are blocked by magnesium ions, which are displaced after agonist-induced depolarization. In humans, memantine administration is associated with different gastrointestinal dysmotility side effects (vomiting, diarrhoea, constipation, motor-mediated abdominal pain), thus limiting its clinical use. Mechanism of these motility disorders has not been clarified yet. Pigs can be used in various preclinical experiments due to their relatively very similar gastrointestinal functions compared to humans. The aim of this study was to evaluate the impact of a single and repeated doses of memantine on porcine gastric myoelectric activity evaluated by means of electrogastrography (EGG)., Methods: Six adult female experimental pigs (Sus scrofa f. domestica, mean weight 41.7±5.0 kg) entered the study for two times. The first EGG was recorded after a single intragastric dose of memantine (20 mg). In the second part, EGG was accomplished after 7-day intragastric administration (20 mg per day). All EGG recordings were performed under general anaesthesia. Basal (15 minutes) and study recordings (120 minutes) were accomplished using an EGG stand (MMS, Enschede, the Netherlands). Running spectral analysis based on Fourier transform was used. Results were expressed as dominant frequency of gastric slow waves (DF) and power analysis (areas of amplitudes)., Results: Single dose of memantine significantly increased DF, from basic values (1.65±1.05 cycles per min.) to 2.86 cpm after 30 min. (p = 0.008), lasting till 75 min. (p = 0.014). Basal power (median 452; inter-quartile range 280-1312 μV^2) raised after 15 min. (median 827; IQR 224-2769; p = 0.386; NS), lasting next 30 min. Repetitively administrated memantine caused important gastric arrhythmia. Basal DF after single and repeated administration was not different, however, a DF increase in the second part was more prominent (up to 3.18±2.16 after 15 and 30 min., p<0.001). In comparison with a single dose, basal power was significantly higher after repetitively administrated memantine (median 3940; IQR 695-15023 μV^2; p<0.001). Next dose of 20 mg memantine in the second part induced a prominent drop of power after 15 min. (median 541; IQR 328-2280 μV^2; p<0.001), lasting till 120 min. (p<0.001)., Conclusions: Both single and repeated doses of memantine increased DF. Severe gastric arrhythmia and long-lasting low power after repeated administration might explain possible gastric dysmotility side effects in the chronic use of memantine., Competing Interests: The authors have declared that no competing interests exist.

Published
2020
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49. Investigation of 23 Bile Acids in Liver Bile in Benign and Malignant Biliary Stenosis: A Pilot Study.

Author

Rejchrt S, Hroch M, Repak R, Fejfar T, Douda T, Kohoutova D, Peterova E, and Bures J

Abstract

Differential diagnosis between benign and malignant biliary stenosis can be difficult in clinical practice. Histology of biopsy specimens is often indeterminate. Laboratory markers (serum bilirubin > 75  μ mol/L, carbohydrate antigen 19-9 > 400 U/mL) and the length of stenosis (>15 mm) can be helpful but are not specific enough. The aim of this study was to investigate bile acids in liver bile of patients with benign and malignant biliary stenosis and controls without stenosis. A total of 73 patients entered the study: 7 subjects with benign biliary stenosis (6 men, 1 woman; 68 ± 13 years old), 21 with malignant biliary stenosis (15 men, 6 women; 72 ± 14 years old), and 45 patients without biliary stenosis (22 men, 23 women; 70 ± 13 years old); out of those, 25 subjects have and 20 do not have choledocholithiasis. Twenty-three different bile acids were investigated by high-performance liquid chromatography/mass spectrometry. Serum total bilirubin was significantly higher in patients with malignant biliary stenosis compared with nonstenotic controls ( p = 0.005). Significant relationship ( r > 0.7) was found between several pairs of bile acids. Significantly lower bile acid concentrations in malignant biliary stenosis compared to controls without stenosis were found for GLCA ( p = 0.032), GUDCA ( p = 0.032), GCDCA ( p = 0.006), GDCA ( p = 0.031), GHCA ( p = 0.005), TUDCA ( p = 0.044), and TDCA ( p = 0.036). Significant difference in cholic acid was found between benign and malignant stenosis ( p = 0.022). Analysis of bile acids might be helpful in the differential diagnosis of malignant and benign biliary stenosis. More patients need to be enrolled in further studies so that the real diagnostic yield of bile acids can be determined., Competing Interests: The authors declare that they have no conflict of interest., (Copyright © 2019 Stanislav Rejchrt et al.)

Published
2019
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50. The prevalence and sociodemographic determinants of uninvestigated dyspepsia in the Czech Republic: a multicentre prospective study accomplished 10 years after the first study from the same geographical areas.

Author

Rejchrt S, Koupil I, Kopáčová M, Škodová Fendrichová M, Seifert B, Voříšek V, Špirková J, Douda T, Tachecí I, and Bureš J

Subjects
Adolescent, Adult, Age Distribution, Age Factors, Aged, Aged, 80 and over, Anti-Bacterial Agents therapeutic use, Child, Child, Preschool, Czech Republic epidemiology, Dyspepsia diagnosis, Dyspepsia microbiology, Educational Status, Female, Helicobacter Infections diagnosis, Helicobacter Infections microbiology, Helicobacter pylori isolation & purification, Humans, Male, Middle Aged, Prevalence, Prognosis, Prospective Studies, Residence Characteristics, Risk Factors, Sex Distribution, Sex Factors, Time Factors, Young Adult, Dyspepsia epidemiology, Helicobacter Infections epidemiology, Socioeconomic Factors
Abstract

Objective: The epidemiology of uninvestigated dyspepsia was studied in the Czech Republic for the first time in 2001. The aim of the current multicenter prospective study was to evaluate dyspepsia using the same methods in a representative sample of general unselected population from the same geographical areas 10 years later., Participants and Methods: A total of 38 147 individuals comprised the general population for a random two-step selection process. A total of 1836 participants (863 males and 973 females; aged 5-98 years) took part in the questionnaire-based study. Helicobacter pylori status was investigated in all participants by means of C-urea breath test., Results: The overall prevalence of dyspepsia was 2.6% among children and adolescents aged 5-17 years and 16.0% among adults aged 18-98 years. We did not detect any statistically significant sex differences in the prevalence of total dyspepsia or its subtypes. Overall, 2.4% of H. pylori-negative children and adolescents aged less than 18 years reported dyspepsia, and 16.8% of H. pylori-negative adults reported it. Among H. pylori-positive children and adolescents and adults, dyspepsia was present in 8.3 and 15.8%, respectively. Type A dyspepsia (as the only long-lasting symptom) was statistically significantly associated with H. pylori status among children and adolescents. Among adults aged 18 years or older, we noted a lower prevalence of dyspepsia in adults with elementary education compared with university education. Current use of antibiotics was associated with an increased prevalence of dyspepsia in adults., Conclusion: Despite the substantial decrease of H. pylori infection in the Czech Republic over the past 10 years, the prevalence and sociodemographic determinants of uninvestigated dyspepsia did not change significantly.

Published
2018
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