Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Colitis Crohn's Disease Colon Crohn's Duodenitis Crohn's Esophagitis Crohn's Gastritis Crohn's Ileocolitis Crohn's Jejunitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases IBD-unclassified (IBD-U) Indeterminate Colitis Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC) Ulcerative Proctitis Ulcerative Proctosigmoiditis

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Emily W Lopes, MD, MPH

CONTACT

[email protected]

617-726-5560

Emily W Lopes, MD, MPH

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of participants who develop inflammatory bowel disease

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily W Lopes, MD, MPH

CONTACT

[email protected]

617-726-5560

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: FIND-IBD

Important dates

Study start: 2024
Primary completion: 2034
Study completion: 2034
First posted: Oct 23, 2024
Registry last updated: Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting