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

Phase

N/A

Condition

Esophageal Disorders

Ulcers

Duodenal Ulcers

Treatment

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

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

Clinical Study ID

NCT05332639

2022p000905

1K23DK136977-01

Ages > 14
All Genders
Accepts Healthy Volunteers

Study 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

Inclusion

Inclusion Criteria:

Ability to give informed consent
Ability and willingness to comply with all patient visits and study-relatedprocedures
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

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 bya modified version of the Harvey-Bradshaw Index for CD activity

Study Design