Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
- Conditions
- Inflammatory Bowel DiseasesCrohn Disease
- Registration Number
- NCT06453720
- Lead Sponsor
- University of British Columbia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br>CD patients<br><br> - Adult patients =19 years old and = 80 years old.<br><br> - CD with distal small bowel and/or colonic involvement that is endoscopically<br> assessable with colonoscopy<br><br> - Undergoing colonoscopy as part of routine clinical care<br><br> - Active or quiescent disease<br><br> - Active disease will be defined as a simple endoscopic score for CD (SES-CD) =7 or =4<br> for isolated ileal CD and at least one large ulcer (=5mm)<br><br> - Quiescent disease is defined as an SES-CD <3.<br><br>Non-IBD controls<br><br> - Adult patients = 19 years old and = 80 years old.<br><br> - Undergoing colonoscopy as part of colorectal screening<br><br>Exclusion Criteria:<br><br>CD patients<br><br> - Active perianal CD - defined as collection on MRI or clinically active fistula<br> (i.e., draining fistula)<br><br> - Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or<br> isolated upper GI CD<br><br> - Antibiotics in the last 3 months for any indication<br><br> - Prebiotic, probiotic or postbiotic supplements in the last month<br><br> - Gastroenteritis or travel outside of Canada and the United States in the last month<br><br> - Colorectal cancer, high-grade dysplasia or a polyp =2cm diagnosed at baseline<br> endoscopy<br><br> - Pregnant or breastfeeding<br><br> - Bowel resection within the preceding 4 months<br><br> - Primary sclerosing cholangitis<br><br>Non-IBD controls<br><br> - Found to have inflammation (deemed by endoscopist) at colonoscopy.<br><br> - History of IBD in 1st degree relative.<br><br> - Antibiotics in the last 3 months.<br><br> - Prebiotic, probiotic or postbiotic supplements in the last month.<br><br> - Gastroenteritis or travel outside of Canada and the United States in the last month.<br><br> - Pregnant or breastfeeding.<br><br> - Previous bowel surgeries.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy as well as fecal samples.;In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict response to therapy after induction (12 - 16 weeks).;In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict sustained response to therapy at 12 Months (+/- 3 months).
- Secondary Outcome Measures
Name Time Method Investigate the correlations between the microbial analyses across different sample types and disease activity in CD.;Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.;Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.;Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.;Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.;Compare the sensitivity of the microbial analyses from each sample type in their prediction of response to therapy.;Compare the specificity of the microbial analyses from each sample type in their prediction of response to therapy.