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NCT05332639NARecruitingAccepts Healthy Volunteers

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

Massachusetts General Hospital

Start Date

10/3/2025

Completion Date

11/1/2027

Summary

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.

Eligibility Criteria

Age Range: 14 years to No maximum

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

Interventions

BEHAVIORAL

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool

BEHAVIORAL

Standard Crohn's Disease Education

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Conditions

Inflammatory Bowel DiseasesCrohn DiseaseCrohn ColitisCrohn's IleocolitisCrohn's GastritisCrohn's JejunitisCrohn's DuodenitisCrohn's Esophagitis

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States