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Observational Study for Family Members at Risk of Inflammatory Bowel Disease

This study is looking for people who have a close family member (parent, child, or sibling) with inflammatory bowel disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. You can join if you are at least 14 years old and do not currently have IBD yourself. The study aims to understand if certain behaviors, diet, or body markers (biomarkers) can help predict who might develop IBD in the future and if it can be prevented. There are no specific treatments or interventions being tested. Participants will be followed for about 10 years, completing a questionnaire and providing blood, stool, and urine samples once a year. The study is currently ongoing, but its exact status is unclear.

Study design
This is an observational study, meaning no interventions are given. It plans to enroll 50 participants to follow over time.
What's involved
You would complete a questionnaire and provide blood, stool, and urine samples once a year for about 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is anticipated to be 10 years.

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NCT06655415

Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

Recruiting
Not specifiedAges 14+Observational
Massachusetts General Hospital
~50 participants
Updated 2024-12-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who develop inflammatory bowel disease
Measured over Through study completion (an anticipated 10 years)

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

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Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Emily W Lopes, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Emily W Lopes, MD, MPH
[email protected]
617-726-5560
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants who develop inflammatory bowel diseaseThrough study completion (an anticipated 10 years)

    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.