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Recruiting Observational

Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome

NCT07517029 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-04-08
Last updated
2026-04-13

Condition(s) studied

IBS - Irritable Bowel SyndromePost Infection Syndrome

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Identification of microbial signatures discriminating PI-IBS from controls — Baseline up to 30 months (end of study)
    Identification of reproducible gut microbiome signatures, including taxonomic and functional profiles, that discriminate patients with post-infectious irritable bowel syndrome (PI-IBS) from control groups using whole genome shotgun sequencing and machine learning approaches.

Trial sites (1)

FacilityCityRegionStatus
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS Rome Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517029 on ClinicalTrials.gov ↗ ← All trials in Italy