Genome Analysis Across Populations in Inflammatory Bowel Disease

Recruiting

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Healthy; Crohn Disease
• Interventions: Genetic: Blood or saliva sample collection

• Registration Number: NCT06042387
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

Objective:

To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.

Detailed Description

Background:

Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the intestines characterized by dysregulation of mucosal immune response. Recent data suggests that the incidence and prevalence rates among all populations may be increasing due to constantly changing environmental exposures. The goal of the study is to identify susceptible genes that contribute to the pathogenesis of IBD in affected individuals.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-05
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, IBD-undetermined)
• Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U))
• Healthy controls: no personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss
• Any age

Exclusion Criteria

• Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD Subjects	Blood or saliva sample collection	Self-identify as: Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age
Controls	Blood or saliva sample collection	Self-identify as: Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry No personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss Any age

Primary Outcome Measures

Name	Time	Method
Genomics studies across populations	2022-2027	Whole Exome Sequencing (+/- other sequencing) is planned

Trial Locations

Locations (1)

Sinai Health System; 🇨🇦 Toronto, Ontario, Canada