Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

American College of Gastroenterology

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

Conditions:

Inflammatory Bowel Diseases

Crohn Disease

Eligibility:

All Genders

14+ years

Phase:

NA

Brief 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 wit...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 14 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT05332639

Start Date

July 14 2025

End Date

May 1 2027

Last Update

January 7 2026

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114