Crohn Disease Clinical Trial
Official title:
Personalized Risk Estimation for Crohn's Disease (PRE-CD): 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-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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | American College of Gastroenterology |
United States,
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
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 |
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