Family Members At INcreased-risk for Developing Inflammatory Bowel Disease
Recruiting · NCT06655415 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States