NCT05332639 Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
| NCT ID | NCT05332639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-03 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Emily Lopes, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05332639 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05332639 currently recruiting?
Yes, NCT05332639 is actively recruiting participants. Contact the research team at mghprecrohns@mgb.org for enrollment information.
Where is the NCT05332639 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05332639 clinical trial?
NCT05332639 is sponsored by Massachusetts General Hospital. The principal investigator is Emily Lopes, MD at Massachusetts General Hospital. The trial plans to enroll 80 participants.