Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06655415

Acronym

FIND-IBD

Enrollment

Registered

2024-10-23

Start date

2024-12-18

Completion date

2034-12-31

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

Inflammatory Bowel Disease, IBD, Ulcerative colitis, Crohn's disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who develop inflammatory bowel disease	Through 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.

Countries

United States

Contacts

Primary ContactEmily W Lopes, MD, MPH

mghfindibd@mgb.org617-726-5560

Outcome results