Actively Recruiting
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
Led by University of British Columbia · Updated on 2026-01-20
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
I
IBD Centre of BC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living in British Columbia, Canada. The main questions this study seeks to answer are: 1. Can microbiome signatures across different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) predict response to therapy in CD? 2. How do microbiome profiles differ between active and quiescent CD and non-IBD controls? Researchers will compare microbiome signatures in patients with active and inactive CD as well as non-IBD controls to see if there are any microbial signatures that predict response to therapy. Participants will: 1. Provide fecal and blood samples. 2. Undergo intestinal washings and intestinal epithelial biopsy specimens taken during routine colonoscopy. 3. Participate in a longitudinal follow-up over 12 months to monitor clinical, biochemical, and endoscopic responses to therapy.
CONDITIONS
Official Title
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 80 years
- Patients with Crohn's disease involving distal small bowel and/or colon, assessable by colonoscopy
- Undergoing colonoscopy as part of routine clinical care
- Having either active or quiescent Crohn's disease
- Active disease defined by simple endoscopic score for Crohn's disease (SES-CD)
- Quiescent disease defined as SES-CD less than 3
- Mild active disease defined as SES-CD 3-6, or 3 with isolated ileal Crohn's disease
- Moderate to severe active disease defined as SES-CD 7 or higher, or 4 or higher for isolated ileal Crohn's disease
- Non-IBD control adults aged 19 to 80 years undergoing colonoscopy for colorectal screening
You will not qualify if you...
- Active perianal Crohn's disease with abscess or draining fistula
- Crohn's disease limited to proximal small bowel or isolated upper gastrointestinal tract not accessible by colonoscopy
- History of colectomy, proctocolectomy, pouch, J-pouch, or reversed pouch surgery
- Diagnosis of short bowel syndrome
- Antibiotic use within the last 2 months
- Gastroenteritis or travel outside Canada and the United States within the last month
- Colorectal cancer, high-grade dysplasia, or polyps 2 cm or larger found at baseline endoscopy
- Pregnancy or breastfeeding
- Bowel resection within the last 4 months
- Primary sclerosing cholangitis
- Non-IBD controls with inflammation found during colonoscopy
- History of inflammatory bowel disease in a first-degree relative
- Previous bowel surgeries in non-IBD controls
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Actively Recruiting
Research Team
F
Fanny LeMarié, PhD
CONTACT
M
Mackenzie Melvin, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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