Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

Last updated: December 18, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Heartburn (Pediatric)

Heartburn

Treatment

N/A

Clinical Study ID

NCT06655415
2024P000791
  • Ages > 14
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

First-degree relatives of people with inflammatory bowel disease ("IBD," including Crohn's disease and ulcerative colitis) have an increased risk for developing IBD themselves. This study will follow unaffected first-degree relatives (who do not have IBD) over time to understand if their behaviors, diet, and biomarkers for IBD can help predict who gets IBD and if IBD can be prevented in these high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. The anticipated length of the study (registry) is approximately 10 years or longer. Parts of this study, such as the questionnaires and stool and urine collection, may be done from home, while other parts, such as the blood draw, will need to be done from Massachusetts General Hospital.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to give informed consent

  • Ability to complete all study visits and study-related procedures

  • Ability to understand and complete study questionnaires

  • Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or IBD-unclassified)

  • Age ≥ 14

Exclusion

Exclusion Criteria:

  • Individuals with existing diagnoses of inflammatory bowel disease (ulcerativecolitis, Crohn's disease, or IBD-unclassified)

  • Evidence of clinical signs or symptoms of IBD, which will be identified onpre-screening interview with the study coordinator.

Study Design

Total Participants: 50
Study Start date:
December 18, 2024
Estimated Completion Date:
December 31, 2034

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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