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Recruiting NCT06655415

Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

Observational Inflammatory Bowel Disease (IBD) Ulcerative Colitis (UC) IBD-unclassified (IBD-U) Indeterminate Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), IBD-unclassified (IBD-U), Indeterminate Colitis. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Family Members At INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)

Overview

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.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT06655415 · 2024P000791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗