Genome Analysis Across Populations in Inflammatory Bowel Disease

March 20, 2025 updated by: Mark Silverberg, Mount Sinai Hospital, Canada

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

IBD or Healthy controls (non-IBD)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD Subjects
Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age Willing to provide blood or saliva sample
Genetic: Blood or saliva sample collection
Blood or saliva sample & clinical data collection
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 Willing to provide blood or saliva sample
Genetic: Blood or saliva sample collection
Blood or saliva sample & clinical data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomics studies across populations
Time Frame: 2022-2027
Whole Exome Sequencing (+/- other sequencing) is planned
2022-2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Mark Silverberg, MD PhD, Sinai Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-0234-E
  • U01DK062423 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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