search
Back to results

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

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
Standard Crohn's Disease Education
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring Crohn's disease

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Comparator arm

Arm Description

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

Standard Crohn's Disease Education

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in blood C reactive protein (CRP) level
We will assess for a decreases in blood CRP level (mg/L) compared to baseline values.
Change in stool calprotectin level
We will assess for a decreases in fecal/stool calprotectin level (mcg/g) compared to baseline values.
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.

Full Information

First Posted
March 28, 2022
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
American College of Gastroenterology
search

1. Study Identification

Unique Protocol Identification Number
NCT05332639
Brief Title
Personalized Risk Estimation for Crohn's Disease (PRE-CD): Implementation and Feasibility
Official Title
Personalized Risk Estimation for Crohn's Disease (PRE-CD): Implementation and Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American College of Gastroenterology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis, Crohn's Gastritis, Crohn's Jejunitis, Crohn's Duodenitis, Crohn's Esophagitis
Keywords
Crohn's disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
Arm Title
Comparator arm
Arm Type
Active Comparator
Arm Description
Standard Crohn's Disease Education
Intervention Type
Behavioral
Intervention Name(s)
Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
Other Intervention Name(s)
Intervention Arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Crohn's Disease Education
Other Intervention Name(s)
Comparator Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in composite Crohn's disease risk score (CD-RS)
Description
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.
Time Frame
6-weeks and 6-months post-intervention
Secondary Outcome Measure Information:
Title
Change in blood C reactive protein (CRP) level
Description
We will assess for a decreases in blood CRP level (mg/L) compared to baseline values.
Time Frame
6-weeks and 6-months post-intervention
Title
Change in stool calprotectin level
Description
We will assess for a decreases in fecal/stool calprotectin level (mcg/g) compared to baseline values.
Time Frame
6-weeks and 6-months post-intervention
Title
Change in blood biomarker positivity
Description
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.
Time Frame
6-weeks and 6-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lopes, MD
Phone
617-726-5560
Email
mghprecd@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Lopes, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily W. Lopes, MD
Phone
617-726-5560
Email
mghprecd@partners.org
First Name & Middle Initial & Last Name & Degree
Emily W. Lopes, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33068181
Citation
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.
Results Reference
background
Links:
URL
https://siteman.wustl.edu/prevention/ydr/
Description
Your Disease Risk

Learn more about this trial

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

We'll reach out to this number within 24 hrs