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First Degree Relative for Crohn's Disease

N/A
Waitlist Available
Led By Dario R Sorrentino, MD, FRACP
Research Sponsored by Dario Sorrentino
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female who are 18-65 years of age
FDR: Has a first degree relative (mother, father, offspring, or full sibling) who has been diagnosed with Crohn's Disease Healthy Controls: Normal colonoscopy and histology (if applicable) results, and no family history of inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up coincident at screening
Awards & highlights

Study Summary

This trial will test whether capsule endoscopy can be used to screen for Crohn's disease in first degree relatives of patients with the disease.

Eligible Conditions
  • Crohn's Disease
  • Genetic Predisposition
  • Inflammatory Bowel Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~coincident at screening
This trial's timeline: 3 weeks for screening, Varies for treatment, and coincident at screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence of Crohn's Disease in First Degree Relatives by capsule endoscopy screening
Secondary outcome measures
Correlation of capsule endoscopy with ileocolonoscopy; characterization of disease state

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: First Degree RelativeExperimental Treatment1 Intervention
A total of 112 high risk first-degree relatives will be enrolled in total. Patients with Crohn's Disease will be given information about the study when in clinic for routine care to share with their first degree relatives (FDR). Screening will be done using capsule endoscopy.
Group II: Healthy ControlsActive Control1 Intervention
This study will also enroll 35 healthy controls who will be age and sex matched to the first degree relative (FDR) population. Enrollment will begin after 20-25 FDR's have passed screening and will continue at this interval until all controls have been enrolled. Controls will be initially screened by colonoscopy. If enrolled they will undergo capsule endoscopy as well
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capsule endoscopy
2009
Completed Phase 4
~830

Find a Location

Who is running the clinical trial?

Dario SorrentinoLead Sponsor
Carilion ClinicLead Sponsor
70 Previous Clinical Trials
12,677 Total Patients Enrolled
Dario R Sorrentino, MD, FRACPPrincipal InvestigatorCarilion Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025