Recruiting

Inflammatory Bowel Disease

Sponsor:

Massachusetts General Hospital

Code:

NCT06655415

Conditions

Inflammatory Bowel Disease (IBD)

Ulcerative Colitis (UC)

IBD-unclassified (IBD-U)

Indeterminate Colitis

Crohn's Disease Colon

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Inflammatory Bowel Disease (IBD)

Ulcerative Colitis (UC)

IBD-unclassified (IBD-U)

Indeterminate Colitis

Crohn's Disease Colon

Study ID

NCT06655415

Start date

Dec 18, 2024

Status verified date

Oct, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Dec, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Emily W Lopes, MD, MPH

617-726-5560mghfindibd@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emily W Lopes, MD, MPH

617-726-5560mghfindibd@mgb.org

Principal Investigator:

Emily W Lopes, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.