Personalized Crohn's risk estimator (PRE-Crohn's) implementation and feasibility
Official title: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Run by Massachusetts General Hospital · NCT05332639 · Data updated 2026-11-12
This project will test a web-based personalized risk tool to see if giving unaffected first-degree relatives of people with Crohn's disease tailored risk information changes their behaviors and early disease markers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 3, 2025 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT05332639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Unaffected first-degree relatives of people with IBD who are older than 14, can give informed consent, and can complete study visits and questionnaires are ideal candidates.
✕Probably not a fit
People who already have a diagnosis of IBD, those with current IBD signs or symptoms, or individuals unable to use the web tool or attend study visits are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Unaffected first-degree relatives of patients with inflammatory bowel disease will use a web-based Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool or receive standard Crohn's disease education. The study will compare changes in behaviors linked to Crohn's risk and pre-clinical biomarkers between the two groups over the study period. Participants must be older than 14, able to consent and complete questionnaires, and have no current diagnosis or clinical signs of IBD. The project will measure whether personalized risk disclosure is feasible and whether it leads to measurable biological or behavioral changes that could inform prevention strategies.
Why it matters
Potential benefit: If successful, the tool could help high-risk relatives adopt healthier behaviors and normalize early biomarkers, potentially reducing the chance of developing Crohn's disease.
How similar studies have gone: Personalized risk-disclosure tools have shown mixed success in changing behavior in other conditions, but this approach is relatively novel and untested specifically for Crohn's disease.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Emily Lopes, MD — Massachusetts General Hospital
- Study coordinator: Emily W Lopes, MD
- Email: mghprecrohns@mgb.org
- Phone: 617-726-5560
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.