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The Biologic Onset of Crohn’s Disease: A Screening Study in First Degree Relatives

September 12, 2019

Overview

Early, aggressive diagnostic and therapeutic approaches have proven to improve chances of success in treating many diseases including colon cancer, diabetes and liver disease. Dario Since Crohn’s disease (CD) is hard to detect in the beginning and often responds poorly to therapy or requires surgery, this trial studies the potential of capsule endoscopy-based screening to, hopefully, diagnose Crohn’s disease in its infancy for first degree relatives of Crohn’s patients who are at risk.

 

Study Information

The study will include two groups. The first will be the experimental group. It will consist of 112 subjects who are high-risk, first degree relatives of people with Crohn’s disease.The comparator group will be 35 healthy individuals who will be matched in sex and age as the at-risk first degree relatives. 

 

Inclusion Criteria

  • All sexes, ages 18-65 years old
  • Willingness to comply with protocol requirements, timelines, and procedures
  • Must be 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

First Degree relatives:

  • 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)

 

Exclusion Criteria

  • Suspected or confirmed diagnosis of inflammatory bowel disease or any other gastrointestinal disease or condition
  • Known medical history of clinically significant cardiovascular, hematologic, orthopedic, rheumatologic, muscular, neurologic (e.g. dementia, seizure disorder, traumatic brain injury), endocrine, ophthalmologic, infectious (e.g. human immunodeficiency virus, tuberculosis, hepatitis), immunologic, renal, pulmonary (e.g. COPD), dermatologic, reproductive, or psychiatric disorders, conditions, or diseases that would present unacceptable risk to study subjects, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject’s participation
  • A systolic blood pressure reading less than or equal to 180 mmHg and/or a diastolic blood pressure reading of less than or equal to 110 mmHg at screening
  • An oral temperature reading of 100.5º F or greater
  • Meets any of the following criteria:
    • Use of systemic non-steroidal anti-inflammatory medication (including low-dose aspirin) within 14 days prior to consent
    • History of oral corticosteroid use within 30 days prior to consent
    • Use of IV corticosteroids within 14 days prior to consent
    • Treatment with IV anti-infectives within 30 days prior to consent
    • Treatment with oral anti-infectives within 14 days prior to consent
  • Previous or current history of malignancy (including fully excised cutaneous basal cell carcinoma and squamous cell carcinoma)
  • History of stem cell or fecal transplant
  • History of clinically significant alcoholism or substance abuse in the last 12 months
  • Currently has an implanted electrical device (e.g., pacemaker)

 

Locations

You may participate in this clinical trial at the Carilion Clinic in Roanoke, Virginia, United States, 24013. If you have any questions or concerns, please feel free to contact Andrea L Bidanset, MS at 540-224-6751 or at albidanset@carilionclinic.org. You may also contact Vu Q Nguyen, MD at 540-206-9226 or at vqnguyen@carilionclinic.org

 

Sponsors/Collaborators

This study is sponsored by the Carilion Clinic with Dario R Sorrentino, MD, FRACP as the Principal Investigator.

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