Status:
TERMINATED
The Biologic Onset of Crohn's Disease: A Screening Study in First Degree Relatives
Lead Sponsor:
Carilion Clinic
Conditions:
Crohn Disease
Genetic Predisposition
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Pursuing very early diagnosis is standard of care for several diseases including colon cancer, diabetes and liver disease where an early and aggressive diagnostic and therapeutic approach has been sho...
Detailed Description
Crohn's Disease (CD) is a form of inflammatory bowel disease (IBD) that affects the gastrointestinal tract. CD is a chronic, remitting, and relapsing disease that is rarely diagnosed at or near its bi...
Eligibility Criteria
Inclusion
- 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)
- 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
Exclusion
- 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 ≥ 180 mmHg and/or a diastolic blood pressure reading of ≥ 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, as defined in the DSM-IV
- Currently has an implanted electrical device (e.g., pacemaker)
- Screening lab results were found to be exclusionary based on the following
Key Trial Info
Start Date :
February 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03291743
Start Date
February 10 2017
End Date
September 30 2022
Last Update
December 13 2022
Active Locations (1)
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1
Carilion Clinic
Roanoke, Virginia, United States, 24013