Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
Qualifiers
* 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.
Disqualifiers
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.
Inclusion criteria
Age ≥ 18 years old
Trial design
Treatments tested in this trial
- Not listed
Trial groups
315 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov