NCT05332639Recruiting
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Mar 2022
- Start date
- 3 Oct 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Crohn's disease
- NCT number
- NCT05332639
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 3 Oct 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Inability to provide informed consent
- Inability to comply with all patient visits and study-related procedures
- Inability to understand or complete study questionnaires
Who the study is looking for
- 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
Age in the registry: 14 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.