Eligibility Details:
Inclusion Criteria:
- 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 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 ≥ 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