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Predicting IBD Treatment Outcomes With Gut Microbiome Analysis

Inflammatory Bowel Diseases | Crohn Disease

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    19 to 80

Participation Criteria

Inclusion Criteria:

CD patients

* 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) ≥7 or ≥4 for isolated ileal CD and at least one large ulcer (≥5mm)
* Quiescent disease is defined as an SES-CD \<3.

Non-IBD controls

* Adult patients ≥ 19 years old and ≤ 80 years old.
* Undergoing colonoscopy as part of colorectal screening

Exclusion Criteria:

CD patients

* 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
* Antibiotics in the last 3 months for any indication
* Prebiotic, probiotic or postbiotic supplements in the last month
* 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 3 months.
* Prebiotic, probiotic or postbiotic supplements in the last month.
* Gastroenteritis or travel outside of Canada and the United States in the last month.
* Pregnant or breastfeeding.
* Previous bowel surgeries.

Study Location

GI Research Institute
GI Research Institute
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Pedram Tavakoli, BSc

Backup Contact

Micah Ten-Pow, BSc

Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT06453720