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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorMassachusetts General Hospital

About this trial

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

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

American College of Gastroenterology

Collaborator

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

Collaborator