Actively Recruiting
Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-04-13
315
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years old
- PI-IBS diagnosed according to Rome IV criteria
- Diagnosis made no earlier than 3 months before enrollment
- Written informed consent and compliance with study procedures
- History of acute infectious gastroenteritis more than 6 months before enrollment (for post-infectious non-IBS control group)
- Complete recovery without persistent gastrointestinal symptoms (for post-infectious non-IBS control group)
- Healthy donors from fecal microbiota transplant or blood donor programs (for healthy control group)
- No history of gastrointestinal or systemic disorders (for healthy control group)
You will not qualify if you...
- Chronic organic gastrointestinal disorders such as inflammatory bowel disease
- Metabolic syndrome, obesity, diabetes, gastrointestinal cancers, or systemic autoimmune disorders
- History of major abdominal surgery
- Current or past diagnosis of irritable bowel syndrome (for post-infectious non-IBS control group)
- Any chronic gastrointestinal or systemic disorders (for post-infectious non-IBS and healthy control groups)
- Recent use of antibiotics or probiotics within 4 weeks (for healthy control group)
- Chronic medication affecting microbiome composition, such as proton pump inhibitors (for healthy control group)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
G
Gianluca Ianiro
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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