Biologic Onset of Crohn’s Disease: A Screening Study in First-Degree Relatives
Using capsule endoscopy-based screening of first-degree relatives of Crohn’s Disease patients we hope to develop early detection tools to diagnose Crohn’s disease at or near its biologic onset.
About
Crohn’s disease (CD) still lags behind, since commonly at presentation, CD has already run a long course and often responds poorly to therapy or requires surgery. Our innovative project proposes a minimally invasive strategy: capsule endoscopy-based screening of first-degree relatives (FDRs) of CD patients to develop tools to diagnose CD at or near its biologic onset.
Eligibility Criteria
Inclusion Criteria
- Male or female who are 18 to 65 years of age
- Has a FDR (mother, father, offspring or full sibling) who has been diagnosed with CD (FDR population); OR colonoscopy and applicable histology results from recent procedure were found to be normal (for healthy controls)
- Willingness to comply with protocol requirements, timelines and procedures
- Able and willing to provide written consent; medical, surgical and medication history; current and concomitant medication use; and any other documents deemed relevant by the investigator
- A negative pregnancy test for all female subjects of childbearing potential at the time of consent; subject must also agree to follow medically approved birth control measures while enrolled
Exclusion Criteria
- Suspected or confirmed diagnosis of inflammatory bowel disease or any other gastrointestinal disease or condition
- Has an implanted electrical device such as a pacemaker
- Known medical history of clinically significant cardiovascular, hematologic, orthopedic, rheumatologic, muscular, neurologic, endocrine, ophthalmologic, immunologic, renal, pulmonary, dermatologic, reproductive or psychiatric disorders, conditions or diseases
Primary Investigator
Dr. Dario Sorrentino, is currently Professor of Medicine at Virginia Tech Carilion School of Medicine and Director of the IBD Center at Carilion Clinic. He also holds a faculty position at the University of Udine Medical School in Italy.
