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Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

Who can join

Ages 14 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Ability to give informed consent
* Ability and willingness to comply with all patient 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 indeterminate colitis/IBD unclassified)
* Individuals greater than 14 years of age

Exclusion Criteria:

* Inability to provide informed consent
* Inability to comply with all patient visits and study-related procedures
* Inability to understand or complete study questionnaires
* Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
* Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

About the study

The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.

What is being tested

• Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool (behavioral)
• Standard Crohn's Disease Education (behavioral)

Sponsor: Massachusetts General Hospital · Participants: 80 · Started: Oct 3, 2025

Contact the study team

• Emily W Lopes, MD · Phone: 617-726-5560

Official record on ClinicalTrials.gov — NCT05332639

Locations in the U.S.

Conditions

• Inflammatory Bowel Disease
• Crohn's Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.