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The multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group (EHMSG) is conducted in 27 countries in Europe. The data from the Russian part of the European registry for the management of Helicobacter pylori infection (European Registry on the management of Helicobacter pylori infection, protocol: "Hp-EuReg") allows us to analyze the real clinical practice of diagnosis and treatment of H. pylori and compare it with international recommendations.A comparative analysis of the data entered in the register by the Russian research centers "Hp-EuReg", in the period from 2013 to 2018, was conducted.Invasive diagnostic methods prevail for the primary diagnosis of H. pylori [histology - 20.3% (in 2013 year) - 43.9% (in 2018 year), rapid urease test - 31.7% and 47.8% respectively]. The most popular mode of eradication therapy is a 10-day triple therapy (62.8-76.2%), the effectiveness of which does not exceed 79% (per protocol). Invasive tests (histology) are the leading method for control the effectiveness of therapy, however, there is a tendency towards a wider use of non-invasive methods (H. pylori stool antigen - from 17% in 2013 to 29.3% in 2018 and urea breath test from 6.9 to 18.3%, respectively). Serological test to control the effectiveness of eradication is still used from 8.2% (2013) to 6.1% (2018). Eradication therapy was not performed in 28% of patients throughout the entire observation period.In Russia, despite approved domestic and international recommendations, deviations in clinical practice persist, both during eradication therapy and in monitoring the effectiveness of eradication therapy.от имени научного комитета и исследователей Hp-EuReg Наблюдательное многоцентровое проспективное исследование, инициированное Европейской группой по изучению Helicobacter pylori и микробиоты (EHMSG), проводится в 27 странах Европы. Данные российской части Европейского регистра ведения инфекции Helicobacter pylori (European Registry on the management of Helicobacter pylori infection, протокол: «Hp-EuReg») позволяют проанализировать реальную клиническую практику диагностики и лечения H. pylori и сопоставить ее с международными рекомендациями. Материалы и методы. Проведен сравнительный анализ данных, внесенных в регистр российскими центрами исследования «Hp-EuReg» в период с 2013 г. по февраль 2018 г. Результаты и обсуждение. Для первичной диагностики H. pylori доминируют инвазивные методы: гистологическое исследование (20,3% в 2013 г. и 43,9% в 2018 г.) и быстрый уреазный тест (31,7 и 47,8% соответственно). Наиболее часто назначаемым режимом эрадикации является 10-дневная тройная терапия (62,8-76,2%), эффективность которой per protocol не превышает 79%. Ведущим методом контроля эффективности остаются инвазивные тесты (гистологическое исследование), однако намечается тенденция к росту применения неинвазивных методов: моноклонального теста на антиген H. pylori в кале (с 17% в 2013 г. до 29,3% в 2018 г.) и уреазного дыхательного теста (с 6,9 до 18,3% соответственно). Серологический тест с целью контроля эрадикации продолжают использовать от 8,2% в 2013 г. до 6,1% в 2018 г. Не проводился контроль у 28% больных. Выводы. В России сохраняются значимые отклонения клинической практики от отечественных и международных рекомендаций, как при проведении эрадикационной терапии, так и на этапе контроля ее эффективности.

On behalf of the scientific Committee and researchers Hp-EuReg European Registry on the management of Helicobacter pylori infection («Hp-EuReg») - a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group, conducted in 27 European countries in order to evaluate the real clinical practice of diagnosis and treatment of H. pylori and its comparison with international recommendations. Materials and methods. The analysis of 2360 patients entered in the register by the Russian centres of «Hp-EuReg» in 2013-2017, who were underwent 1st line eradication therapy. Results. The most common methods of primary diagnosis of H. pylori are histological (37.7%), rapid urease test (29.2%) and serology (29.7%). The duration of eradication therapy in 9.4% of cases was 7 days, in 65.3% - 10 days, and in 25.3% - 14 days. To control the effectiveness of treatment, H. pylori antigen in feces (31.3%), urea breath test (23.4%) and histological method (23.3%) were used. In 3.6% cases was used serology by mistake. In 17.3% of patients control was not carried out. The effectiveness of triple therapy with a PPI, amoxicillin, clarithromycin (per protocol) was 67.6%, with 7-day course, 81.1% at 10-day and 86.7% at 14-day course. Еradication rate of triple therapy with addition of bismuth (per protocol) reached 90,6% in the group receiving 10-day scheme and 93.6% in the group receiving the 14-day treatment. Conclusion. Significant deviations of clinical practice from expert recommendations, most pronounced at the stage of monitoring the effectiveness of therapy, were noted. The suboptimal efficacy of triple therapy is shown.

Background At present only monoclonal EIA (enzyme-immunoassay) stool antigen-tests have obtained optimal accuracy in the diagnosis of Helicobacter pylori. Our aim was to evaluate the accuracy of two stool antigen-tests, the validated Premier Platinum HpSA PLUS (EIA test) and the newly available ImmunoCard STAT! HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection. Patients and methods Patients with indication of H. pylori diagnosis, or confirmation after treatment were included. Data were coded to protect personal data and ensure blindness between tests. Accuracy was considered as coincident diagnosis with the gold standard (13C-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate. Results 264 patients completed the protocol (100 naive, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naive and 17% for post-eradication. Overall ImmunoCard and EIA accuracies were respectively 91% (95% C . I . = 88–94%) and 89% (86–93%), sensitivities 72% (67–78%) and 72% (67–78%), and specificities 98% (96–100%), and 95% (92–97%). Concordance between ImmunoCard and EIA was 95% (93–98%). Discussion Our results indicate that the newly available ImmunoCard rapid stool antigen-test achieves 90% accuracy, with high specificity but suboptimal sensitivity. The ImmunoCard attained equivalent accuracies as the EIA bench standard, with 95% concordance.

To evaluate the safety, tolerability and efficacy of a probiotic supplementation for Helicobacter pylori (H. pylori) eradication therapy.Consecutive adult naive patients with a diagnosis of H. pylori infection who were prescribed eradication therapy according to clinical practice (10-day triple or nonbismuth quadruple concomitant therapy) randomly received probiotics (1 × 10A total of 209 patients (33% triple therapy, 66% non-bismuth quadruple therapy) were included [placebo (n = 106) or probiotic (n = 103)]. No differences were observed regarding side effects at the end of the treatment between groups (β -0.023, P 0.738). Female gender (P 0.001) and quadruple therapy (P 0.007) were independent predictors of side effects. No differences in compliance were observed, regardless of the study group or eradication therapy. Eradication rates were similar between groups [placebo 95% (95% confidence interval (CI), 89% to 98%) vs probiotic 97% (95% CI, 92% to 99%), P 0.721]. There were no relevant differences in cure rates (90% in all cases) between triple and quadruple concomitant therapy.Probiotic supplementation containing Lactobacillus Plantarum and Pediococcus acidilactici to H. pylori treatment neither decreased side effects nor improved compliance with therapy or eradication rates.

Background A progressive decrease in Helicobacter pylori eradication rates has been described over the years, driving the need for new antibiotic treatments. Aim To evaluate the efficacy and safety of the addition of rifaximin (Spiraxin ® ) to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori . Methods Independent prospective clinical trial (EUDRACT no.: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first five patients enrolled to evaluate the safety of the treatment. H. pylori eradication was confirmed with the 13 C-urea breath test at least four weeks after the end of treatment with rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h and omeprazole 20 mg/12 h for 10 days. Results Forty patients were consecutively enrolled, 53% woman, mean age 44 years. Indication for eradication: 60% non-investigated dyspepsia, 38% functional dyspepsia and 2% gastric ulcer. Four patients did not attend the eradication confirmatory breath test. The eradication rate was 61% (95% CI: 45–77%) for the protocol and 55% (40–70%) for intention-to-treat. About 76% of the patients experienced adverse events (35% diarrhea, 14% nausea and 24% metallic taste), none of which was serious. The blood tests did not show significant alterations. Conclusion Acceptable H. pylori eradication rates are not achieved with rifaximin associated with standard triple therapy for 10 days.

OBJECTIVES: The objective of this study was (a) To know the prevalence and distribution of extracolonic cancer (EC) in patients with inflammatory bowel disease (IBD); (b) To estimate the incidence rate of EC; (c) To evaluate the association between EC and treatment with immunosuppressants and anti-tumor necrosis factor (TNF) agents. METHODS: This was an observational cohort study. Inclusion criteria: IBD and inclusion in the ENEIDA Project (a prospectively maintained registry) from GETECCU. Exclusion criteria: Patients with EC before the diagnosis of IBD, lack of relevant data for this study, and previous treatment with immunosuppressants other than corticosteroids, thiopurines, methotrexate, or anti-TNF agents. The Kaplan-Meier method was used to evaluate the impact of several variables on the risk of EC, and any differences between survival curves were evaluated using the log-rank test. Stepwise multivariate Cox regression analysis was used to investigate factors potentially associated with the development of EC, including drugs for the treatment of IBD, during follow-up. RESULTS: A total of 11,011 patients met the inclusion criteria and were followed for a median of 98 months. Forty-eight percent of patients (5,303) had been exposed to immunosuppressants or anti-TNF drugs, 45.8% had been exposed to thiopurines, 4.7% to methotrexate, and 21.6% to anti-TNF drugs. The prevalence of EC was 3.6%. In the multivariate analysis, age (HR=1.05, 95% CI=1.04-1.06) and having smoked (hazards ratio (HR)=1.47, 95% confidence interval (CI)=1.10-1.80) were the only variables associated with a higher risk of EC. CONCLUSIONS: Neither immunosuppressants nor anti-TNF drugs seem to increase the risk of EC. Older age and smoking were associated with a higher prevalence of EC.

To assess the clinical practice of diagnosis and treatment in patients with Helicobacter pylori infection and to compare this practice with the international guidelines in the European Registry on the management of Helicobacter pylori infection, Hp-EuReg protocol), a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group. MATERIALs AND METHODS: The data of 813 patients infected with H. pylori and entered in the Hp-EuReg register by the Russian centers in 2013-2015 were analyzed.The most common methods for the primary diagnosis of H. pylori infection are histology (40.3%), rapid urease test (35.7%), and serology (17.2%). The duration of H. pylori eradication therapy was 7, 10, and 14 days in 18.0, 49.3, and 25.1%, respectively. To monitor the effectiveness of treatment, the investigators used a histological examination (34%), a urea breath test (27.3%), H. pylori stool antigen (22.8%), and a rapid urease test (16.3%). A serological test was carried out in 2.5% of the cases. No monitoring was done in 13.5% of the patients. The average eradication efficiency was 82.6%. If the therapy was ineffective, 80% of physicians did not intend to prescribe a new cycle of treatment.Significant differences were found between clinical practice and the current guidelines.Цель исследования. Оценка клинической практики диагностики и лечения больных с инфекцией Helicobacter pylori и сопоставление этой практики с международными рекомендациями в Европейском регистре (European Registry on the management of Helicobacter pylori infection, протокол: 'Hp-EuReg') - наблюдательном многоцентровом проспективном исследовании, инициированном Европейской группой по изучению H. pylori и микробиоты (EHMSG). Материалы и методы. Проведен анализ данных 813 больных, инфицированных H. pylori и внесенных в регистр Российскими центрами исследования 'Hp-EuReg' в 2013-2015 гг. Результаты. Наиболее распространенными методами первичной диагностики инфекции H. pylori являются гистологический (40,3%), быстрый уреазный тест (35,7%) и серологический (17,2%). Длительность антихеликобактерной терапии в 18% случаев составила 7 дней, в 49,3% - 10 дней, в 25,1% - 14 дней. Для контроля эффективности лечения используются гистологический метод (34%), уреазный дыхательный тест (27,3%), антиген H. pylori в кале (22,8%), быстрый уреазный тест (16,3%). В 2,5% случаев использовался серологический метод. У 13,5% больных контроль не проводился. Средняя эффективность эрадикации составила 82,6%; 80% врачей в случае неэффективности терапии не намерены назначать новый курс лечения. Заключение. Выявлены значительные отличия клинической практики от современных рекомендаций.

Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, Gyorgy M. Buzas, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert

Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, Gyorgy M. Buzas, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert

Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, Gyorgy M. Buzas, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert

Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, Gyorgy M. Buzas, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert