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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Ileocolitis; Crohn's Gastritis; Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis; Inflammatory Bowel Disease (IBD); Crohn's Colitis; Indeterminate Colitis; Ulcerative Colitis (UC); Ulcerative Proctitis; Ulcerative Proctosigmoiditis; Crohn's Disease Colon; IBD-unclassified (IBD-U)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Emily W Lopes, MD, MPH; Phone Number: 617-726-5560; Email: mghfindibd@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Emily W Lopes, MD, MPH; Phone Number: 617-726-5560; Email: mghfindibd@mgb.org
      • Contact: Emily W Lopes, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion (an anticipated 10 years)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Emily W Lopes, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; IBD; Crohn's disease; Ulcerative colitis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Rectal Diseases; Colonic Diseases; Esophageal Diseases; Gastroenteritis; Enteritis; Duodenal Diseases; Sigmoid Diseases; Colitis; Colitis, Ulcerative; Ulcer; Crohn Disease; Gastritis; Intestinal Diseases; Inflammatory Bowel Diseases; Esophagitis; Proctitis; Duodenitis; Proctocolitis
• Other Study ID Numbers: 2024P000791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be available upon reasonable request and per Mass General Brigham IRB guidelines as outlined in the ICF and detailed protocol.
• IPD Sharing Access Criteria: Collaborators interested in requesting data must submit a valid scientific question, include a statistical analysis plan, complete a data request form, and Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No