NCT07517029 Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
| NCT ID | NCT07517029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | IBS - Irritable Bowel Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 315 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 315 participants in total. It began in 2026-04-08 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Gianluca Ianiro
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07517029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IBS - Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07517029 currently recruiting?
Yes, NCT07517029 is actively recruiting participants. Contact the research team at gianluca.ianiro@policlinicogemelli.it for enrollment information.
Where is the NCT07517029 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07517029 clinical trial?
NCT07517029 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Gianluca Ianiro at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 315 participants.