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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Crohn Colitis; Crohn's Ileocolitis; Crohn's Gastritis; Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis
• Intervention / Treatment: Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool; Behavioral: Standard Crohn's Disease Education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily W Lopes, MD; Phone Number: 617-726-5560; Email: mghprecrohns@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Emily W. Lopes, MD
      • Contact: Emily W. Lopes, MD; Phone Number: 617-726-5560; Email: mghprecrohns@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparator arm; Standard Crohn's Disease Education	Behavioral: 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.; Other Names: Comparator Arm
Experimental: Intervention Arm; Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool	Behavioral: 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.; Other Names: Intervention Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion	The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey.	1.5 years and time of study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to change smoking behavior	We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase)	8 weeks and 6 months
Motivation to change diet	We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase)	8 weeks and 6 months
Motivation to change physical activity	We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase)	8 weeks and 6 months
Change in physical activity	We will measure change in physical activity (MET-hours/week)	8 weeks and 6 months
Change in fruit intake	We will measure change in fruit intake (servings/day)	8 weeks and 6 months
Change in vegetable intake	We will measure change in vegetable intake (servings/day)	8 weeks and 6 months
Change in processed meat intake	We will measure change in processed meat intake (servings/day)	8 weeks and 6 months
Change in fiber intake	We will measure change in fiber intake (grams/day)	8 weeks and 6 months
Change in added sugar intake	We will measure change in added sugar intake (grams/day)	8 weeks and 6 months
Change in smoking behaviors	We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day	8 weeks and 6 months
Change in C-reactive protein (CRP; mg/L)	We will measure change in CRP (mg/L)	8 weeks and 6 months
Change in fecal calprotectin (mcg/g)	We will measure change in fecal calprotectin (mcg/g)	8 weeks and 6 months
Change in seropositivity for antimicrobial biomarkers	We will measure several Crohn's disease associated antimicrobial biomarkers including ASCA IgA and IgG, anti-OmpC, anti-CBir1, anti-A4-Fla2 and anti-FlaX will be assayed using the PROMETHEUS® IBD sgi Diagnostic® panel. Positivity for each of these components are defined as follows: ASCA IgA > 9.2 EU/mL; ASCA IgG > 11.9 EU/mL; anti-OmpC > 11.3 EU/mL; anti-CBir1 > 35.4 EU/mL; anti-A4-Fla2 > 32.4 EU/mL and anti-FlaX > 36.0 EU/mL. Total biomarker positivity (secondary outcome) will be defined as the presence of 1 or more positive individual biomarkers above. We will then assess for change in total biomarker positivity at 8 weeks and 6 months compared to baseline.	8 weeks and 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American College of Gastroenterology
• Investigators: Principal Investigator: Emily Lopes, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Colditz GA, Dart H. Commentary: 20 years online with "Your Disease Risk". Cancer Causes Control. 2021 Jan;32(1):5-11. doi: 10.1007/s10552-020-01356-3. Epub 2020 Oct 17.

Helpful Links

• Your Disease Risk
• NIH Reporter Prevention of Crohns Disease in High-Risk Individuals

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Crohn's disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases; Equipment and Supplies
• Other Study ID Numbers: 2022p000905; 1K23DK136977-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregate-level results of from this study will be reported on clinicaltrials.gov. De-identified individual-level data will be uploaded to a separate controlled access repository and can be available upon reasonable request and per controlled access repository standard terms and procedures.
• IPD Sharing Time Frame: All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• IPD Sharing Access Criteria: A controlled repository will be used to store and protect individual patient data. To access data arising from this project, users must complete a data request form and Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No