Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

Recruiting

• Conditions: Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis; Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); IBD-unclassified (IBD-U); Indeterminate Colitis; Crohn's Disease Colon

• Registration Number: NCT06655415
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-23
• Status Verified: 2024-12
• Study Start: 2024-12-18
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2034-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 Criteria

• Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or IBD-unclassified)
• Evidence of clinical signs or symptoms of IBD, which will be identified on pre-screening interview with the study coordinator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who develop inflammatory bowel disease	Through study completion (an anticipated 10 years)	Participants will be queried annually on questionnaires for the development of inflammatory bowel disease (IBD), including Crohn's disease, ulcerative colitis, or IBD-U (self-reported outcome). Participants will then be asked for permission to obtain additional medical records, which will be reviewed by study investigators to confirm diagnosis of IBD.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States