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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05332639
• Other study ID #: 2022p000905
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2025
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Emily Lopes, MD
• Phone: 617-726-5560
• Email: mghprecd[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
We will develop a web-based, personalized risk estimation for CD (PRE-CD) 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, vegetables, and fiber, oral contraceptive use (females), 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-CD tool as well.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in composite Crohn's disease risk score (CD-RS)	A composite Crohn's disease risk score (CD-RS) will be constructed that summarizes participants' behavioral and dietary patterns associated with risk for Crohn's disease. Higher CD-RS scores will reflect increased exposure to CD risk factors. Our primary outcome will be a binary outcome (yes/no) for achieving a one-point decrease in CD-RS.	6-weeks and 6-months post-intervention
Secondary	Change in blood C reactive protein (CRP) level	We will assess for a decreases in blood CRP level (mg/L) compared to baseline values.	6-weeks and 6-months post-intervention
Secondary	Change in stool calprotectin level	We will assess for a decreases in fecal/stool calprotectin level (mcg/g) compared to baseline values.	6-weeks and 6-months post-intervention
Secondary	Change in blood biomarker positivity	We will assess for a reduction in seropositivity for one of several Crohn's disease biomarkers (p-antineutrophil cytoplasmic antibody, anti-saccharomyces cerevisiae antibody immunoglobulin A (IgA) and immunoglobulin G (IgG), anti-outer membrane protein C IgA, and anti-flagellins anti-CBir1 IgG, anti-A4-Fla2 IgG and anti-FlaX IgG). Each biomarker will be assessed as "positive" or "negative" if a biomarker is present or absent, respectfully. The outcome will be a binary outcome (yes/no) for achieving a change from a positive to negative biomarker for disease.	6-weeks and 6-months post-intervention

External Links

•   Your Disease Risk