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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05332639
• Lead Sponsor: Massachusetts General Hospital

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-CD) 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-CD 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Study Start: 2025-05-01
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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)
• Individuals greater than 14 years of age

Exclusion Criteria

• Inability to provide informed consent
• Inability or unwillingness 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)
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool	Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
Comparator arm	Standard Crohn's Disease Education	Standard Crohn's Disease Education

Primary Outcome Measures

Name	Time	Method
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion	1.5 years and time of study completion	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.

Secondary Outcome Measures

Name	Time	Method
Motivation to change smoking behavior	8 weeks and 6 months	We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase)
Motivation to change diet	8 weeks and 6 months	We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase)
Motivation to change physical activity	8 weeks and 6 months	We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase)
Change in physical activity	8 weeks and 6 months	We will measure change in physical activity (MET-hours/week)
Change in fruit intake	8 weeks and 6 months	We will measure change in fruit intake (servings/day)
Change in vegetable intake	8 weeks and 6 months	We will measure change in vegetable intake (servings/day)
Change in processed meat intake	8 weeks and 6 months	We will measure change in processed meat intake (servings/day)
Change in fiber intake	8 weeks and 6 months	We will measure change in fiber intake (grams/day)
Change in added sugar intake	8 weeks and 6 months	We will measure change in added sugar intake (grams/day)
Change in smoking behaviors	8 weeks and 6 months	We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day
Change in C-reactive protein (CRP; mg/L)	8 weeks and 6 months	We will measure change in CRP (mg/L)
Change in fecal calprotectin (mcg/g)	8 weeks and 6 months	We will measure change in fecal calprotectin (mcg/g)
Change in seropositivity for antimicrobial biomarkers	8 weeks and 6 months	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States