Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
Healthy Volunteers
NCT05332639

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

Led by Massachusetts General Hospital · Updated on 2026-01-30

80

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

A

American College of Gastroenterology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

E

Emily W Lopes, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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