Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453720
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-22
Brief Title:
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMIST
Brief Summary:
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohns 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
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
Detailed Description:
Inflammatory bowel disease IBD is a chronic and relapsing inflammatory condition affecting the gastrointestinal GI tract The study aims to evaluate microbiome profiles bacteriome and mycobiome across three different sample types fecal intestinal washings and intestinal epithelial biopsies in a cohort of adult patients with Crohns disease CD living in British Columbia Canada and investigate whether a microbial signature may predict response to IBD therapy
Aims
1 Determine microbiome signatures across different sample types in quiescent and active disease for patients with CD living in BC Canada
2 Evaluate whether fecal mucosal andor intestinal epithelial biopsy microbiome signatures can predict response to therapy
Methods
Study Design
Phase 1 A cross-sectional pilot study to evaluate the microbiome in patients with IBD with active and quiescent disease and in non-IBD controls
Primary Outcome 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
Secondary Outcomes Investigate correlations between the microbial analyses across different sample types and disease activity in CD Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients Investigate if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome in a subset of patients with CD
Phase 2 A longitudinal observational study with a 12-month follow-up
Primary Outcome Identify if there are any microbial signatures that predict response to therapy in patients with active disease requiring escalated therapy assessed clinically and biochemically after induction 12-16 weeks and at 12 months - 3 months
Secondary Outcomes Compare the sensitivity and specificity of microbial analyses from each sample type in predicting response to therapy
Aims
1 Determine microbiome signatures across different sample types in quiescent and active disease for patients with CD living in BC Canada
2 Evaluate whether fecal mucosal andor intestinal epithelial biopsy microbiome signatures can predict response to therapy
Methods
Study Design
Phase 1 A cross-sectional pilot study to evaluate the microbiome in patients with IBD with active and quiescent disease and in non-IBD controls
Primary Outcome 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
Secondary Outcomes Investigate correlations between the microbial analyses across different sample types and disease activity in CD Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients Investigate if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome in a subset of patients with CD
Phase 2 A longitudinal observational study with a 12-month follow-up
Primary Outcome Identify if there are any microbial signatures that predict response to therapy in patients with active disease requiring escalated therapy assessed clinically and biochemically after induction 12-16 weeks and at 12 months - 3 months
Secondary Outcomes Compare the sensitivity and specificity of microbial analyses from each sample type in predicting response to therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None