Family Members at INcreased-risk for Developing Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial population

First-degree relatives (FDRs) of those with IBD.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Individuals who have a parent, sibling, or child with IBD but who do not have IBD themselves

Trial outcomes

Primary outcomes

1

Number of participants who develop inflammatory bowel disease

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.

Time frame
Through study completion (an anticipated 10 years)

Secondary outcomes

Other outcomes

Sponsors and contacts

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