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Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome

Recruitingn/aAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gemโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). The study will compare microbiome composition and function between PI-IBS patients and two control groups (post-infectious subjects without irritable bowel syndrome -IBS- and healthy controls), with the goal of identifying reproducible microbial signatures and target taxa associated with disease and symptom severity.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
PI-IBS patients (n = 105) * Inclusion criteria * Age โ‰ฅ 18 years old * PI-IBS diagnosed according to Rome IV criteria (33). * Diagnosis no earlier than 3 months before enrollment. * Written informed consent and compliance with study procedures. * Exclusion criteria * Chronic organic gastrointestinal (GI) disorders (e.g. Inflammatory Bowel Disease -IBD), metabolic syndrome, obesity, diabetes, GI cancers, systemic autoimmune disorders. * History of major abdominal surgery. Control cohort #1 - Post-infectious non-IBS (n = 105) * Inclusion criteria * Age โ‰ฅ 18 years old * History of acute infectious gastroenteritis \>6 months before enrollment. * Complete recovery without persistent GI symptoms. * Exclusion criteria * Current or past diagnosis of IBS. * Any chronic GI or systemic disorders. Control cohort #2 - Healthy subjects (n = 105) * Inclusion criteria * Age โ‰ฅ 18 years old * Healthy donors from FMT program or blood donor program. * No history of GI or systemic disorders. * Exclusion criteria * Any GI or systemic chronic condition. * Recent antibiotics/probiotics (\<4 weeks). * Chronic medication affecting microbiome composition (e.g. PPI)
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What it tests

  • Not listed
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Where

1 site
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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