Predicting treatment outcomes for Crohn's disease using gut microbiome analysis

Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics

This study is trying to see if certain gut bacteria can help predict how well treatments will work for adults with Crohn's disease in British Columbia.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06453720 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify specific microbiome signatures that can predict therapeutic responses in adult patients with Crohn's disease living in British Columbia, Canada. Researchers will analyze microbiome profiles from fecal samples, intestinal washings, and biopsies taken during routine colonoscopy to determine differences between active and quiescent disease states. The study will involve longitudinal follow-up over 12 months to monitor clinical outcomes and assess the correlation between microbiome signatures and treatment responses.

Who should consider this trial

Good fit: Ideal candidates include adult patients aged 19 to 80 with Crohn's disease who are undergoing colonoscopy as part of routine clinical care.

Not a fit: Patients with active perianal Crohn's disease or those who have taken antibiotics or certain supplements recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for patients with Crohn's disease based on their microbiome profiles.

How similar studies have performed: Other studies have shown promising results in using microbiome analysis to predict treatment outcomes in inflammatory bowel diseases, suggesting this approach has potential.

Eligibility 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).
* 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.

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.
* 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

Vancouver, British Columbia

• GI Research Institute — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Study coordinator: Fanny LeMarié, PhD

Conditions: Inflammatory Bowel Diseases, Crohn Disease, IBD, Biologic Therapy, Immunology, Gastrointestinal Tract