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

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

Recruiting
14 years and older
All
Phase N/A

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Overview

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

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 details
    Inflammatory Bowel Diseases
    Crohn Disease
    Crohn Colitis
    Crohn's Ileocolitis
    Crohn's Gastritis
    Crohn's Jejunitis
    Crohn's Duodenitis
    Crohn's Esophagitis

NCT05332639

Massachusetts General Hospital

17 September 2025

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