Family members at INcreased risk for Developing Inflammatory Bowel Disease (FIND-IBD) Study
Published: 10/03/2024
General Information:
To create a high-risk for inflammatory bowel disease research cohort, by enrolling individuals who have a first-degree relative (parent sibling, or child) with inflammatory bowel disease (IBD; including Crohn’s disease, ulcerative colitis, or IBD unclassified/indeterminate colitis), but who do not have one of these diseases themselves.
To monitor behaviors, diet, and biomarkers of IBD in these unaffected first-degree relatives over time, to better understand how to predict and prevent the development of IBD in high-risk individuals.
Eligibility:
Inclusion Criteria:
- Ability to give informed consent
- Ability and willingness to comply with all study visits and study-related procedures
- Ability to understand and complete study questionnaires
- Must have at least one first-degree relative (such as a parent, sibling, or child) with inflammatory bowel disease (such as Crohn’s disease, ulcerative colitis, or IBD-unclassified)
- Age greater than 14 years of age (those 14-17 must have a parent or guardian to consent)
Exclusion Criteria:
- Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn’s disease, or IBD-unclassified)
- Evidence of signs or symptoms of IBD, which will be identified during a screening phone call
Study Details:
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 over time to understand if their behaviors, diet, and biomarkers for IBD can help us predict who gets IBD and if we can prevent IBD development in high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. We hope to continue this study for 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.
Patient Participation Requirements
Once per year, participants will be asked to complete a study questionnaire, have their height and weight measured, and have their blood, urine and stool collected.
At the initial study visit (only), participants will also meet with a dietician to conduct a 4-day food record.
Questionnaires will ask participants about their demographics (level of education, sex, race, and ethnicity), medical history (including what medications you take/have taken, medical diagnoses, and surgical history), family history (including which family members have IBD and what type), physical activity/exercise habits, eating habits/diet, and behaviors such as smoking habits.
Blood will be collected at the main study site at the Massachusetts General Hospital. Participants will be given a stool collection kit with a pre-paid shipping return label that can be completed at home and mailed back to the study team. Urine can be collected either at home, or during the scheduled visit for the blood draw.
Patients who are diagnosesd with IBD during the study follow-up period may be asked to provide additional information about their diagnosis.
Possible risks and side effects:
Stool Collection
Accidental exposure to preservatives in the stool collection materials may cause skin irritation. These preservatives can be washed off with soap and water.
Blood Sampling
Blood sampling carries minor risks including brief pain, bruising, feeling faint when blood is drawn, or rarely infections, which can be treated. Research staff performing blood draws will use MGH standard sanitization procedures to minimize these risks.
Confidentiality
There is a risk of breach of confidentiality involving your protected health information. To minimize this risk, study codes will be used instead of our name on all samples and health information. Study staff with do everything in their power to prevent breaches in confidentiality.