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
This trial accepts healthy volunteersQualifiers
* 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 population
Participants will include adults with post-infectious irritable bowel syndrome (PI-IBS) (n= 105) and two control groups: individuals with a history of acute gastroenteritis without persistent gastrointestinal symptoms (n = 105) , and healthy subjects (n = 105) . All participants will be recruited from clinical centers and donor programs and will undergo clinical assessment and stool sample collection for microbiome analysis.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
315 Participants
are grouped into 3 trial groupsGroup A: Post-infectious-IBS patients
Group B: Post-infectious non-IBS controls
Group C: Healthy controls
Trial outcomes
Primary outcomes
1
Identification of microbial signatures discriminating PI-IBS from controls
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.
Time frame
Baseline up to 30 months (end of study)Secondary outcomes
1
Association between microbiome features and disease severity
Evaluation of associations between gut microbiome composition and function and disease activity, as measured by the IBS Severity Scoring System (IBS-SSS).
Time frame
Baseline up to 30 months (end of study)Sponsors and contacts
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Source ClinicalTrials.gov