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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

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

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

We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool.

BEHAVIORAL

Standard Crohn's Disease Education

The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well.

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

American College of Gastroenterology

OTHER

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Massachusetts General Hospital

OTHER

NCT05332639 - Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility | Biotech Hunter | Biotech Hunter