Predicting IBD Treatment Outcomes With Gut Microbiome Analysis

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adult patients ≥19 years old and ≤ 80 years old.
• CD with distal small bowel and/or colonic involvement that is endoscopically assessable with colonoscopy.
• Undergoing colonoscopy as part of routine clinical care.
• Active or quiescent disease.
• Active disease will be defined as a simple endoscopic score for CD (SES-CD).
• Quiescent disease is defined as an SES-CD <3.
• Mild active disease will be defined as a SES-CD of 3-6, or 3 with isolated ileal CD.
• Moderate/severe active disease will be defined as a simple endoscopic score for CD (SES-CD) ≥ 7 or ≥ 4 for isolated ileal CD. Non-IBD controls:
• Adult patients ≥ 19 years old and ≤ 80 years old.
• Undergoing colonoscopy as part of colorectal screening.

🚫 You may not be able to join if…

• Active perianal CD - defined as collection on MRI or clinically active fistula (i.e., draining fistula).
• Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or isolated upper GI CD.
• Colectomy or Proctocolectomy.
• Pouch, J-Pouch or Reversed pouch surgery.
• Short Bowel Syndrome (SBS) diagnosis.
• Antibiotics in the last 2 months for any indication.
• Gastroenteritis or travel outside of Canada and the United States in the last month.
• Colorectal cancer, high-grade dysplasia or a polyp ≥2cm diagnosed at baseline endoscopy.
• Pregnant or breastfeeding.
• Bowel resection within the preceding 4 months.
• Primary sclerosing cholangitis. Non-IBD controls:
• Found to have inflammation (deemed by endoscopist) at colonoscopy.
• History of IBD in 1st degree relative.
• Antibiotics in the last 2 months.
• Gastroenteritis or travel outside of Canada and the United States in the last month.
• Pregnant or breastfeeding.
• Previous bowel surgeries.

Where this trial is running

• GI Research Institute, Vancouver, British Columbia, Canada

Who to contact

Fanny LeMarié, PhD · 6044414992 · flemarie@ibdcentrebc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06453720.