Find Irritable Bowel Syndrome (IBS) Clinical Trials Near You
Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
⁃ 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.
Locations
Other Locations
Italy
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Gianluca Ianiro
gianluca.ianiro@policlinicogemelli.it
+390630155701
Time Frame
Start Date:2026-04-08
Estimated Completion Date:2028-12
Participants
Target number of participants:315
Treatments
Post-infectious-IBS patients
Patients diagnosed with post-infectious irritable bowel syndrome (PI-IBS) according to Rome IV criteria. Participants must be ≥18 years old and diagnosed within 3 months prior to enrollment. Clinical data, including IBS severity scoring system (IBS-SSS), medical history, diet, and lifestyle factors will be collected. Stool samples will be collected at baseline and at monthly follow-up visits for 3 months.
Post-infectious non-IBS controls
Adults ≥18 years old with a history of acute infectious gastroenteritis occurring more than 6 months prior to enrollment, with complete recovery and no persistent gastrointestinal symptoms or diagnosis of IBS. One stool sample and associated clinical and lifestyle data will be collected at enrollment.
Healthy controls
Healthy adult subjects ≥18 years old with no history of gastrointestinal or systemic disorders, recruited from fecal microbiota transplantation (FMT) or blood donor programs. Participants must not have taken antibiotics or probiotics within 4 weeks prior to enrollment. One stool sample and associated demographic and lifestyle data will be collected at enrollment.