Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome (NCT07517029) | Clinical Trial Compass
RecruitingNot Applicable
Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
Italy315 participantsStarted 2026-04-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PI-IBS patients (n = 105)
* Inclusion criteria
* Age ≥ 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 ≥ 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 ≥ 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of microbial signatures discriminating PI-IBS from controls
Timeframe: Baseline up to 30 months (end of study)