Inflammatory Bowel Disease (IBD)FIND-IBDNCT06655415
Family Members at INcreased-risk for Developing Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to Dec 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: First-degree relatives (FDRs) of those with IBD.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emily W Lopes, MD, MPH, 617-726-5560, mghfindibd@mgb.org
Emily W Lopes, MD, MPH
About this study
Official title: Family Members at INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)
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, Crohn's Colitis
- Keywords
- Inflammatory Bowel Disease, IBD, Ulcerative colitis, Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (an anticipated 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start18 Dec 2024
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily R. Lopes, MD, MPH, Massachusetts General Hospital
- Investigators
- Emily W Lopes, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655415
- Sponsor's protocol ID
- 2024P000791
- Acronym
- FIND-IBD
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be available upon reasonable request and per Mass General Brigham IRB guidelines as outlined in the ICF and detailed protocol.