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4. Postcholecystectomy Pain

Author

Corazziari, Enrico Stefano, Pallotta, Nadia, Lacy, Brian E., editor, DiBaise, John K., editor, Pimentel, Mark, editor, and Ford, Alexander C., editor

Published
2019
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6. Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial

Author

Corazziari, Enrico Stefano, primary, Gasbarrini, Antonio, additional, D'Alba, Lucia, additional, D'Ovidio, Valeria, additional, Riggio, Oliviero, additional, Passaretti, Sandro, additional, Annibale, Bruno, additional, Cicala, Michele, additional, Repici, Alessandro, additional, Bassotti, Gabrio, additional, Ciacci, Carolina, additional, Di Sabatino, Antonio, additional, Neri, Matteo, additional, Bragazzi, Maria Consiglia, additional, Ribichini, Emanuela, additional, Radocchia, Giulia, additional, Iovino, Paola, additional, Marazzato, Massimiliano, additional, Schippa, Serena, additional, and Badiali, Danilo, additional

Published
2023
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7. Poliprotect vs Omeprazole in the relief of heartburn, epigastric pain and burning in patients without erosive esophagitis and gastro-duodenal lesions: A Randomized, Controlled Trial

Author

Corazziari, Enrico Stefano, Gasbarrini, Antonio, D'Alba, Lucia, D'Ovidio, Valeria, Riggio, Oliviero, Passaretti, Sandro, Annibale, Bruno, Cicala, Michele, Repici, Alessandro, Bassotti, Gabrio, Ciacci, Carolina, Di Sabatino, Antonio, Neri, Matteo, Bragazzi, Maria Consiglia, Ribichini, Emanuela, Radocchia, Giulia, Iovino, Paola, Marazzato, Massimiliano, Schippa, Serena, Badiali, Danilo, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Corazziari, Enrico Stefano, Gasbarrini, Antonio, D'Alba, Lucia, D'Ovidio, Valeria, Riggio, Oliviero, Passaretti, Sandro, Annibale, Bruno, Cicala, Michele, Repici, Alessandro, Bassotti, Gabrio, Ciacci, Carolina, Di Sabatino, Antonio, Neri, Matteo, Bragazzi, Maria Consiglia, Ribichini, Emanuela, Radocchia, Giulia, Iovino, Paola, Marazzato, Massimiliano, Schippa, Serena, Badiali, Danilo, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)

Abstract

Background: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, anti-reflux agents, and mucosal protective agents (MPA) are widely used, alone or as add-on treatment to increase response to proton pump inhibitors, which are not indicated in infancy and pregnancy, and account for significant cost expenditure. Aims methods: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of MPA Poliprotect (neoBianacid®) versus Omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with Omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks, and on-demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on demand. Gut microbiota change was assessed. Results: A 2-week treatment with Poliprotect proved non-inferior to Omeprazole for symptom relief (between-group difference in the change in VAS symptom score: [mean, 95% CI] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; ITT and PP populations, respectively).Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of Omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% CI: Poliprotect 3.9, 2.8-5.0; Omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. Conclusions: Poliprotect proved non-inferior to standard-dose Omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastro-duodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT Database (2015-005216-15).

Published
2023

8. Protective Mechanisms of Liquid Formulations for Gastro-Oesophageal Reflux Disease in a Human Reconstructed Oesophageal Epithelium Model

Author

Ceriotti,Laura, Buratti,Paolo, Corazziari,Enrico Stefano, Meloni,Marisa, Ceriotti,Laura, Buratti,Paolo, Corazziari,Enrico Stefano, and Meloni,Marisa

Abstract

Laura Ceriotti,1 Paolo Buratti,1 Enrico Stefano Corazziari,2 Marisa Meloni1 1In vitro Innovation Center, VitroScreen srl, Milan, Italy; 2Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano (Milan), ItalyCorrespondence: Laura Ceriotti, VitroScreen, in vitro Innovation Center, Via Mosè Bianchi, 103, Milan, 20149, Italy, Email laura.ceriotti@vitroscreen.comPurpose: A novel experimental design based on a human-reconstructed oesophageal epithelium (HO2E) model has been applied to quantitively assess the properties of a set of liquid formulations, Device A (Gerdoff® Protection), Device B (Esoxx® One), and Device C (Marial® gel) developed to form a temporary physical barrier on the oesophageal epithelium and modify epithelial permeability so to protect the oesophageal mucosa from refluxate components.Methods: The formulations were applied to a prewetted HO2E model for 15 min. Then, a 0.5% caffeine solution was applied, and its penetration kinetics was assessed at 1 h and 2 h in acidic environments (pH= 3.3) to mirror exposure of the oesophageal mucosa to acidic reflux in GORD patients. Caffeine permeated into the basolateral compartment (evaluated by HPLC-UV) and Lucifer yellow (LY) permeability were quantified 15 min after application of the caffeine in acidic environments.Results: At the 15 min timepoint, Device A reduced caffeine permeation by 77.2% and LY flux by 30.4% compared to the untreated control and with a faster mode of action than that of the other liquid formulations. Transepithelial caffeine flux was reduced, albeit with different timing and efficiency, by all three compounds up to the end of the 2 hour experiment. At 1 h, Device A reduced the caffeine flux by 79.2%; Device B, by 67.2%; and Device C, by 37%.Conclusion: These results confirm the ability of the medical devices tested to interact with the oesophageal epithelium and create a temporary physical protective film for up to 2 hours after their application. The results under

Published
2022

14. Persistent Systemic Microbial Translocation, Inflammation, and Intestinal Damage During Clostridioides difficile Infection

Author

Oliva, Alessandra, primary, Aversano, Lucia, additional, De Angelis, Massimiliano, additional, Mascellino, Maria Teresa, additional, Miele, Maria Claudia, additional, Morelli, Sergio, additional, Battaglia, Riccardo, additional, Iera, Jessica, additional, Bruno, Giovanni, additional, Corazziari, Enrico Stefano, additional, Ciardi, Maria Rosa, additional, Venditti, Mario, additional, Mastroianni, Claudio Maria, additional, and Vullo, Vincenzo, additional

Published
2019
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15. The central role of psychopathology and its association with disease severity in inflammatory bowel disease and irritable bowel syndrome

Author

Piacentino, Daria, Cesarini, Monica, Badiali, Danilo, Pallotta, Nadia, Biondi, Massimo, and Corazziari, Enrico Stefano

Subjects
Adult, Male, Analysis of Variance, Mental Disorders, Middle Aged, Inflammatory Bowel Diseases, Severity of Illness Index, Checklist, psychiatry and mental health, Irritable Bowel Syndrome, Crohn Disease, Case-Control Studies, Humans, Colitis, Ulcerative, Female, Symptom Assessment, Aged
Abstract

Biopsychosocial models for both organic and functional gastrointestinal (GI) disorders can be found in the literature. To clarify the role of psychopathological factors and their relationship with GI symptom severity, several studies have examined them in inflammatory bowel disease (IBD) - occasionally distinguishing between ulcerative colitis (UC) and Crohn's disease (CD) - and in irritable bowel syndrome (IBS), leading to unclear results.We aimed to evaluate the psychopathological features of IBD and IBS patients in comparison with healthy individuals and assess the association with disease severity.Sixty-nine IBD outpatients, of which 35 UC and 34 CD, and 75 IBS ones were consecutively recruited at the third level Gastroenterological Center of our University Hospital; 76 healthy controls were also recruited. The psychological status was assessed with the Symptom Checklist-90-Revised (SCL-90-R).IBD and IBS patients showed significantly higher scores on the SCL-90-R Global Severity Index (GSI) and subscales than controls (all p-values0.001), and IBS patients showed significantly higher GSI, depression, and anxiety scores than IBD patients (all p-values0.01). Psychopathology was comparable between UC and CD patients. In IBD and IBS patients the SCL-90-R GSI was significantly associated with disease severity (p0.001).The presence of chronic bowel symptoms, either organic or functional, is linked to a greater severity of psychopathology compared to the general population, possibly as a consequence of higher loads of stress due to the symptoms affecting everyday life. In both IBD and IBS patients, greater disease severity and worse psychopathological functioning are related.

Published
2019

16. Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products#.

Author

Bilia, Anna Rita, Corazziari, Enrico Stefano, Govoni, Stefano, Mugelli, Alessandro, and Racchi, Marco

Subjects
*BIOLOGICAL products, *GOVERNMENT regulation, *RULES, *MEDICAL equipment laws, *MEDICAL equipment safety measures, *COMMERCIAL product evaluation, *DIFFUSION of innovations, *LAW, EQUIPMENT & supply standards
Abstract

The novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of "medical devices made of substances", which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term "medical devices made of substances". This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances. [ABSTRACT FROM AUTHOR]

Published
2021
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17. Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products#.

Author

Bilia, Anna Rita, Corazziari, Enrico Stefano, Govoni, Stefano, Mugelli, Alessandro, and Racchi, Marco

Subjects
*BIOLOGICAL products, *SAFETY, *HERBAL medicine, *GOVERNMENT regulation, *RULES, *MEDICAL equipment laws, *MEDICAL equipment safety measures, *COMMERCIAL product evaluation, *QUALITY assurance, *NEW product development laws, *DIFFUSION of innovations, *MEDICAL equipment, *LAW, EQUIPMENT & supply standards
Abstract

The novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of "medical devices made of substances", which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term "medical devices made of substances". This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances. [ABSTRACT FROM AUTHOR]

Published
2021
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18. Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products#.

Author

Bilia, Anna Rita, Corazziari, Enrico Stefano, Govoni, Stefano, Mugelli, Alessandro, and Racchi, Marco

Subjects
EQUIPMENT & supply standards, BIOLOGICAL products, GOVERNMENT regulation, RULES, MEDICAL equipment laws, MEDICAL equipment safety measures, COMMERCIAL product evaluation, DIFFUSION of innovations, LAW
Abstract

The novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of "medical devices made of substances", which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term "medical devices made of substances". This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances. [ABSTRACT FROM AUTHOR]

Published
2021
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19. Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products#.

Author

Bilia, Anna Rita, Corazziari, Enrico Stefano, Govoni, Stefano, Mugelli, Alessandro, and Racchi, Marco

Subjects
EQUIPMENT & supply standards, BIOLOGICAL products, SAFETY, HERBAL medicine, GOVERNMENT regulation, RULES, MEDICAL equipment laws, MEDICAL equipment safety measures, COMMERCIAL product evaluation, QUALITY assurance, NEW product development laws, DIFFUSION of innovations, MEDICAL equipment, LAW
Abstract

The novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of "medical devices made of substances", which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term "medical devices made of substances". This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances. [ABSTRACT FROM AUTHOR]

Published
2021
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22. Postbiotic Protective Activity of Lactobacillus Rhamnosus GG-Derived Factors on Pathogen Lipopolysaccharide (LPS)-Induced Damage of Human Colonic Smooth Muscle

Author

Cicenia, Alessia, Santangelo, Floriana, Gambardella, Lucia, Iebba, Valerio, Scirocco, Annunziata, Marignani, Michela, Chirletti, Piero, Pallotta, Lucia, Carabotti, Marilia, Corazziari, Enrico Stefano, Schippa, Serena, Severi, Carola, Cicenia, Alessia, Santangelo, Floriana, Gambardella, Lucia, Iebba, Valerio, Scirocco, Annunziata, Marignani, Michela, Chirletti, Piero, Pallotta, Lucia, Carabotti, Marilia, Corazziari, Enrico Stefano, Schippa, Serena, and Severi, Carola

Published
2015

32. Bowel Frequency and Defecatory Patterns in Children: A Prospective Nationwide Survey

Author

Corazziari, Enrico Stefano, Annamaria, Staiano, Erasmo, Miele, Luigi, Greco, Pediatric Gastroenterology Hepatology Italian Society, O. F., Nutrition, Corazziari, E, Staiano, A, Miele, E, and Greco, L.

Subjects
Male, Pediatrics, medicine.medical_specialty, Constipation, Nationwide survey, law.invention, Randomized controlled trial, law, Surveys and Questionnaires, Internal medicine, medicine, Humans, Prospective Studies, Child, Defecation, Prospective cohort study, Response rate (survey), Anus Diseases, Hepatology, business.industry, Gastroenterology, Infant, Rectal Diseases, Italy, Socioeconomic Factors, Child, Preschool, Female, Analysis of variance, medicine.symptom, business
Abstract

Very little is known about several aspects of bowel habits in the general pediatric population and the aim of this nationwide survey was to assess bowel frequency and modalities of defecation in children.The survey was conducted by 58 pediatricians who were selected randomly and distributed evenly throughout Italy. The following items were reported by each pediatrician in a standardized questionnaire: sociodemographic data, frequency and modalities of bowel evacuation, and anorectal disorders.The response rate of available completed questionnaires was distributed evenly for the 1-year age group and was 94% (number of patients, 2680; 1-2 years, 442; females, 49.8%). Mean bowel frequency did not vary in the first 2 years of life, it decreased (P = .00001) after the second year, and remained stable until the 12th year; it did not differ between sexes. Mean bowel frequency was reduced significantly in children, both in those younger or older than 2 years, with a positive history of constipation in the parents (P = .00002). Bowel frequency was inversely correlated with the number of persons living and the number of rooms in the child's house (P.05, P = .008, respectively). Stool consistency, duration of evacuation, and frequency of episodes of painful defecation showed an inverse relationship (P.001) with bowel frequency. Bowel frequency was significantly lower (P.001) in children with anorectal disorders.In Italian children, bowel frequency does not differ between sexes but it differed between the first 2 years of life and age older than 2. Anorectal disorders increase as bowel frequency decreases.

Published
2005

36. Protective Role of Postbiotic Mediators Secreted by Lactobacillus rhamnosus GG Versus Lipopolysaccharide-induced Damage in Human Colonic Smooth Muscle Cells

Author

Cicenia, Alessia, primary, Santangelo, Floriana, additional, Gambardella, Lucrezia, additional, Pallotta, Lucia, additional, Iebba, Valerio, additional, Scirocco, Annunziata, additional, Marignani, Massimo, additional, Tellan, Guglielmo, additional, Carabotti, Marilia, additional, Corazziari, Enrico Stefano, additional, Schippa, Serena, additional, and Severi, Carola, additional

Published
2016
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37. A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of long-term treatment with prucalopride

Author

UCL - (SLuc) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Piessevaux, Hubert, Corazziari, Enrico Stefano, Rey, Enrique, Simren, Magnus, Wiechowska-Kozlowska, Anna, Kerstens, René, Cools, Marina, Barrett, Karen, Levine, Amy, UCL - (SLuc) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Piessevaux, Hubert, Corazziari, Enrico Stefano, Rey, Enrique, Simren, Magnus, Wiechowska-Kozlowska, Anna, Kerstens, René, Cools, Marina, Barrett, Karen, and Levine, Amy

Abstract

Background: Randomized trials have confirmed the efficacy of prucalopride for the treatment of chronic constipation up to 12 weeks. This study aimed to assess the efficacy of prucalopride over a 24-week period (ClinicalTrials.gov: NCT01424228). Methods: Adults with chronic constipation and ≤2 spontaneous complete bowel movements (SCBMs)/week were randomized to receive prucalopride 2 mg or placebo daily for 24 weeks. The primary endpoint was the proportion of patients achieving a mean of ≥3 SCBMs/week over the treatment period, assessed using daily e-diaries. Secondary outcomes and safety parameters were assessed throughout the study. Key Results: Overall, 361 patients were randomized and received prucalopride or placebo. Baseline characteristics were similar in the prucalopride (N = 181) and placebo (N = 180) groups. Mean age was 48.9 years (standard deviation, 16.0) and most patients were women. The proportion of participants achieving the primary endpoint was not statistically different between the prucalopride and placebo groups (25.1% vs 20.7%; p = 0.367). There was also no statistically significant difference between groups over the first 12-week period (prucalopride, 25.1%; placebo, 20.1%; p = 0.341). There were no statistically significant differences between groups for most secondary endpoints. No new safety concerns were identified. Conclusions & Inferences: This trial did not show statistically significant improvements in primary or secondary outcomes with prucalopride compared with placebo over 24 or 12 weeks. This is in contrast to the results of four previous 12-week trials, which demonstrated prucalopride to be significantly more effective than placebo. An extensive evaluation did not provide an explanation for the null efficacy results of this study.

Published
2015

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