Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ 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) ≥7 or ≥4 for isolated ileal CD and at least one large ulcer (≥5mm)

• Quiescent disease is defined as an SES-CD \<3.

⁃ Non-IBD controls

• Adult patients ≥ 19 years old and ≤ 80 years old.

• Undergoing colonoscopy as part of colorectal screening

Locations
Other Locations
Canada
GI Research Institute
RECRUITING
Vancouver
Contact Information
Primary
Fanny LeMarié, PhD
flemarie@ibdcentrebc.ca
6044414992
Backup
Cristian Massaro, BSc
cristian.massaro@bcchr.ca
5872235248
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 100
Treatments
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 send in their stool sample one week prior to their day of colonoscopy or two weeks after their scoping.
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 send in their stool sample one week prior to their day of colonoscopy or two weeks after their scoping.
Sponsors
Collaborators: IBD Centre of BC, GI Research Institute, Pacific Gastroenterology Associates
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov

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