Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06655415
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Dec 18, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2034
Completion
Dec 31, 2034

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of participants who develop inflammatory bowel disease [ Time Frame: Through study completion (an anticipated 10 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Emily W Lopes, MD, MPH
[email protected]
617-726-5560
Emily W Lopes, MD, MPH

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Massachusetts General Hospital· Boston, MA

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