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Personalized Risk Estimation Tool for Crohn's Disease

N/A
Waitlist Available
Led By Emily Lopes, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years and time of study completion
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study the feasibility and effect of a web-based tool that predicts risk for Crohn's disease and provides personalized education on the disease. The goal is to see if this tool can change behaviors associated with Crohn's disease risk and normalize pre-clinical disease biomarkers.

Who is the study for?
This trial is for individuals over 14 years old who have a first-degree relative with inflammatory bowel disease but do not show signs of the disease themselves. They must be able to understand and fill out questionnaires, give informed consent, and follow all study procedures.
What is being tested?
The study tests a web-based tool called PRE-CD that estimates personal risk for Crohn's Disease against standard education on the condition. It aims to see if this tool can change behaviors and improve biomarkers related to Crohn's Disease risk in high-risk individuals.
What are the potential side effects?
Since this trial involves an educational tool rather than medication, traditional side effects are not expected. However, participants may experience stress or anxiety from learning about their personalized risk factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a close family member with inflammatory bowel disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with an inflammatory bowel disease.
Select...
I show signs of inflammatory bowel disease according to a specific health index.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years and time of study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years and time of study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
Secondary study objectives
Change in C-reactive protein (CRP; mg/L)
Change in added sugar intake
Change in fecal calprotectin (mcg/g)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
Group II: Comparator armActive Control1 Intervention
Standard Crohn's Disease Education

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,752 Total Patients Enrolled
American College of GastroenterologyOTHER
37 Previous Clinical Trials
6,788 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,351 Total Patients Enrolled

Media Library

Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool Clinical Trial Eligibility Overview. Trial Name: NCT05332639 — N/A
Inflammatory Bowel Disease Research Study Groups: Comparator arm, Intervention Arm
Inflammatory Bowel Disease Clinical Trial 2023: Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool Highlights & Side Effects. Trial Name: NCT05332639 — N/A
Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05332639 — N/A
~53 spots leftby Nov 2026
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