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NCT05332639 | NOT YET RECRUITING | Inflammatory Bowel Diseases

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

Massachusetts General Hospital

Information provided by (Responsible Party):

Emily R. Lopes, MD, MPH

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 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.

Condition or disease

Inflammatory Bowel Diseases

Crohn Disease

Crohn Colitis

Crohn's Ileocolitis

Crohn's Gastritis

Crohn's Jejunitis

Crohn's duodenitis

Crohn's Esophagitis

Intervention/treatment

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

Standard Crohn's Disease Education

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

Location Details

NCT05332639

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114