Recruiting

Gut Microbiome Analysis

Sponsor:

University of British Columbia

Code:

NCT06453720

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Colonoscopy

Study Details

Brief summary:

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.

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Study ID

NCT06453720

Start date

Aug 1, 2024

Status verified date

Jan, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Crohn's disease

The study will include 75 consenting patients with Crohn's disease, varying in levels of severity depending on assigned SES-CD scoring from their gastroenterologist. These patients will be undergoing routine colonoscopy as per their normal care routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope.

Patients without inflammatory bowel disease

The study will include 25 non-IBD age and sex-matched controls to compare data alongside the CD patients. These patients will be undergoing routine colonoscopy as per their normal colon screening routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope.

Interventions

Colonoscopy

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.

Primary outcome measure

  • Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy as well as fecal samples. [ Time Frame: 24 months ]
  • In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict response to therapy after induction (12 - 16 weeks). [ Time Frame: 24 months ]
  • In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict sustained response to therapy at 12 Months (+/- 3 months). [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Fanny LeMarié, PhD

6044414992flemarie@ibdcentrebc.ca

Mackenzie Melvin, MSc

7788072068mackenzie.melvin@ubc.ca

Locations

GI Research Institute

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

More Information

Sponsor

University of British Columbia

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • IBD
  • Crohn Disease
  • Biologic Therapy
  • Immunology
  • Gastrointestinal Tract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-01-20.