NCT06453720Recruiting
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 22 May 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- University of British Columbia
- Diseases
- Crohn's disease
- NCT number
- NCT06453720
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Aug 2024 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pouch, J-Pouch or Reversed pouch surgery.
- Bowel resection within the preceding 4 months.
- Previous bowel surgeries.
Other illness
- Active perianal CD - defined as collection on MRI or clinically active fistula (i.e., draining fistula).
- Short Bowel Syndrome (SBS) diagnosis.
- Colorectal cancer, high-grade dysplasia or a polyp ≥2cm diagnosed at baseline endoscopy.
- History of IBD in 1st degree relative.
Other
- CD patients:
- Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or isolated upper GI CD.
- Colectomy or Proctocolectomy.
- Antibiotics in the last 2 months for any indication.
- Gastroenteritis or travel outside of Canada and the United States in the last month.
- Pregnant or breastfeeding.
- Primary sclerosing cholangitis.
- Non-IBD controls:
- Found to have inflammation (deemed by endoscopist) at colonoscopy.
- Antibiotics in the last 2 months.
- Gastroenteritis or travel outside of Canada and the United States in the last month.
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GI Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.