RecruitingNCT06453720

Predicting IBD Treatment Outcomes With Gut Microbiome Analysis

Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics


Sponsor

University of British Columbia

Enrollment

100 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study analyzes the gut microbiome — the trillions of bacteria living in the digestive tract — to predict how patients with Crohn's disease will respond to treatment. Stool samples collected during routine colonoscopies will be compared between Crohn's patients and healthy people having routine cancer screening. **You may be eligible if...** - You are aged 19–80 with Crohn's disease involving the lower small bowel or colon (assessable by colonoscopy) - You are already scheduled for a colonoscopy as part of your routine care - OR you are a healthy adult having a routine colorectal cancer screening colonoscopy (as a control participant) **You may NOT be eligible if...** - You have active perianal Crohn's (fistula or abscess) - You have had a colectomy or other major bowel surgery - You took antibiotics in the past 2 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

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.


Locations(1)

GI Research Institute

Vancouver, British Columbia, Canada

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NCT06453720


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