Characterizing gut microbiota in chronic gastrointestinal diseases
The Role of Gut Microbiota in Chronic GI Diseases: A Pilot Study
This study is trying to understand the gut bacteria of people with chronic digestive issues like IBS, IBD, and celiac disease to see how it affects their symptoms and explore new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06532110 on ClinicalTrials.gov |
What this trial studies
This study aims to characterize the microbiota of patients suffering from various chronic gastrointestinal disorders, including IBS, IBD, and celiac disease. It involves collecting data through questionnaires and biological samples such as stool, blood, and tissue during endoscopy or colonoscopy. Additionally, a translational phase will utilize germ-free mice colonized with feces from these patients to compare symptoms, microbiota composition, and histological changes in both the gut and brain. The goal is to understand the role of microbiota in these diseases and explore potential treatment implications.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with IBD, celiac disease, IBS, severe motility disorders, or functional diarrhea.
Not a fit: Patients who have taken antibiotics or probiotics in the last month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new biomarkers and treatment strategies for chronic gastrointestinal disorders.
How similar studies have performed: Other studies have shown promise in understanding the microbiota's role in gastrointestinal diseases, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Premysl Bercik, MD
- Email: bercikp@mcmaster.ca
- Phone: 905 521 2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.