Crohn'sRecruiting
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
Observational · No treatment assigned · 1 site · University of British Columbia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 19 to 80
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 9 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2024-08-01.
- Main results expected around 2026-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy… (24 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease |
| Lead sponsor | University of British Columbia |
| Collaborators | IBD Centre of BC; GI Research Institute; Pacific Gastroenterology Associates |
| Enrollment | 100 (estimated) |
| Start date | 2024-08-01 |
| Primary completion (est.) | 2026-07-01 |
| First posted | 2024-06-12 |
| Last updated | 2026-01-20 |
| Official title | Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics |
| ClinicalTrials.gov ID | NCT06453720 |
Interventions
- Colonoscopy (Procedure)
A colonoscopy will be performed as part of routine clinical care for all participants, with the study not requiring any additional scheduling commitments outside of routine care.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| GI Research Institute | Vancouver, British Columbia | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.