Recruiting

Gut Microbiota

Sponsor:

McMaster University

Code:

NCT06532110

Conditions

Microbiota

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Endoscopy/Colonoscopy

Study Details

Brief summary:

The study involves characterizing the microbiota of patients with IBS, functional diarrhea, IBD, severe motility disorders and celiac disease.

This will be complemented by a translational phase of human-mouse hybrid experiments in which germ-free mice will be colonized with feces from these patients with different GI disease and non-disease controls and we will compare symptoms, microbiota composition and histological changes in the gut and in the brain of the mice.

Conditions

Microbiota

Study ID

NCT06532110

Start date

Oct 1, 2012

Status verified date

Jul, 2024

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosis of IBD, active celiac disease (aTTG positive + endoscopic view and histological findings compatible), IBS (Rome IV criteria or physician diagnosis) severe motility disorders (severe constipation, severe functional dyspepsia) gluten sensitivity (IBS diarrhea predominant with positive anti gliadin antibodies and negative aTTG), functional diarrhea (Rome IV criteria), anal fissure and/or fistula or non-disease control individual or 1st degree family member of celiac patient.
  • Willingness to participate
  • Signed Informed Consent

Exclusion Criteria:

  • Antibiotics in the last month
  • Probiotics in the previous month

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic gastrointestinal disorders

A cohort of 260 patients (150 diagnosed with IBD, 40 with IBS, 30 with celiac disease, 10 with MC, 10 with functional diarrhea and 30 non-disease controls) of either sex between 18 and 75 years of age consulting to either the GI Clinical Investigation, the Endoscopy Unit (McMaster University)

Interventions

Endoscopy/Colonoscopy

Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection

Primary outcome measure

  • To identify different patterns of intestinal microbiota in patients diagnosed with chronic gastrointestinal disorders or controls [ Time Frame: October 2013 - October 2026 ]

Central Contacts and Locations

Central contacts

Premysl Bercik, MD

905 521 2100bercikp@mcmaster.ca

Gaston Rueda, MD

9055212100ruedag@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Gaston H Rueda, MD

905 521-2100ruedag@mcmaster.ca

Andrea Nardelli, MD

905-521-2100nardela@mcmaster.ca

Principal Investigator:

Premysl Bercik, MD

More Information

Sponsor

McMaster University

Last update posted

Aug 1, 2024

Last verified

Jul, 2024

Keywords

  • microbiota
  • chronic gastrointestinal disorders
  • colonization
  • metabolites

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-08-01.