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Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
NCT05332639 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this 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.
Eligibility criteria
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
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-10-03
Estimated completion: 2027-11
Last updated: 2026-01-30
Interventions
Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) toolBehavioral: Standard Crohn's Disease Education
Primary outcomes
- • Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion (1.5 years and time of study completion)
Sponsor
Massachusetts General Hospital · other
With: American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactEmily W Lopes, MD · contact · mghprecrohns@mgb.org · 617-726-5560
InvestigatorEmily Lopes, MD · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States