RecruitingNCT07517029

Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome

Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

315 participants

Start Date

Apr 8, 2026

Study Type

OBSERVATIONAL

Conditions

IBS - Irritable Bowel Syndrome Post Infection Syndrome

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

Min Age: 18 Years

Inclusion Criteria11

PI-IBS patients (n = 105)
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.
Age ≥ 18 years old
History of acute infectious gastroenteritis >6 months before enrollment.
Complete recovery without persistent GI symptoms.
Age ≥ 18 years old
Healthy donors from FMT program or blood donor program.
No history of GI or systemic disorders.

Exclusion Criteria9

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)
Current or past diagnosis of IBS.
Any chronic GI or systemic disorders.
Control cohort #2 - Healthy subjects (n = 105)
Any GI or systemic chronic condition.
Recent antibiotics/probiotics (<4 weeks).
Chronic medication affecting microbiome composition (e.g. PPI)