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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks and 6-months post-intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-weeks and 6-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-weeks and 6-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks and 6-months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in composite Crohn's disease risk score (CD-RS)

Secondary outcome measures

Change in blood C reactive protein (CRP) level

Body Weight Changes

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

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

Group II: Comparator armActive Control1 Intervention

Standard Crohn's Disease Education

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

American College of GastroenterologyOTHER

37 Previous Clinical Trials

6,781 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,193 Total Patients Enrolled

Emily Lopes, MDPrincipal InvestigatorMassachusetts General Hospital

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being registered for this experiment?

"Per information on clinicaltrials.gov, this trial has ceased its search for candidates as of 10/11/2022. Despite the conclusion of participant recruitment, there are still 454 other open studies that require volunteers at this time."

Answered by AI