Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

NCT06655415 | Recruiting

• 1 other identifier: 2024P000791
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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; Crohn's Colitis; Crohn's Ileocolitis; Crohn's Gastritis; Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Emily W Lopes, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily W Lopes, MD, MPH

CONTACT

617-726-5560; mghfindibd@mgb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)