Family Members At INcreased-risk for Developing Inflammatory Bowel Disease
Purpose
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.
Conditions
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis (UC)
- IBD-unclassified (IBD-U)
- Indeterminate Colitis
- Crohn's Disease Colon
- Crohn's Colitis
- Crohn's Ileocolitis
- Crohn's Gastritis
- Crohn's Jejunitis
- Crohn's Duodenitis
- Crohn's Esophagitis
- Ulcerative Proctitis
- Ulcerative Proctosigmoiditis
Eligibility
- Eligible Ages
- Over 14 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Individuals who have a parent, sibling, or child with IBD but who do not have IBD themselves | Adult and adolescent (greater than 14 years of age) first-degree relatives (parents, siblings, or children) of patients with inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or inflammatory bowel disease-unclassified/indeterminate colitis) but who do not have inflammatory bowel disease themselves. |
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital