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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05332639
Status
Recruiting
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Conditions

  • Crohn Colitis
  • Crohn Disease
  • Crohn's Duodenitis
  • Crohn's Esophagitis
  • Crohn's Gastritis
  • Crohn's Ileocolitis
  • Crohn's Jejunitis
  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool — BEHAVIORAL
    We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool.
  • Standard Crohn's Disease Education — BEHAVIORAL
    The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well.

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Arm
    Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
  • Active Comparator: Comparator arm
    Standard Crohn's Disease Education

Primary Outcome Measure

Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion [ Time Frame: 1.5 years and time of study completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Emily W. Lopes, MD
[email protected]
617-726-5560
Emily W. Lopes, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MA

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