Recruiting

PRE-Crohn's

Sponsor:

Massachusetts General Hospital

Code:

NCT05332639

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Crohn Colitis

Crohn's Ileocolitis

Crohn's Gastritis

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

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

Standard Crohn's Disease Education

Study Details

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.

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Crohn Colitis

Crohn's Ileocolitis

Crohn's Gastritis

Study ID

NCT05332639

Start date

Oct 3, 2025

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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

active comparator: Comparator arm

Standard Crohn's Disease Education

Interventions

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

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

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.

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 and Locations

Central contacts

Emily W Lopes, MD

617-726-5560mghprecrohns@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emily W. Lopes, MD

617-726-5560mghprecrohns@mgb.org

Principal Investigator:

Emily W. Lopes, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Crohn's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-30.