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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Emily W Lopes, MD
mghprecrohns@mgb.org
617-726-5560
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2026-11
Participants
Target number of participants: 80
Treatments
Experimental: Intervention Arm
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
Active_comparator: Comparator arm
Standard Crohn's Disease Education
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American College of Gastroenterology
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov