Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02889393
Eligibility Criteria:
Inclusion Criteria:
* Age \>18
* Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia
Exclusion Criteria:
* Perianal fistula
* Clinical suspicion of inflammatory bowel disease
* History of radiation enteritis or sprue (as defined by history)
* Active (\<1 year) alcohol or drug abuse
* Significant hepatic, or cardiac diseases as defined as:
* Hepatic: aspartate aminotransferase (AST) \> 2 times upper limit of normal (10-40 U/L)
* Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
* Severe renal dysfunction: serum creatinine \> 2 times upper limit of normal (0.6-1.5 mg/dL)
* Received glutamine less than 4 weeks prior to screening
* Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
* Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
* Active malignancy or suspicion for gastrointestinal malignancy on CT scan
* Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
* Family history of intestinal malignancy (gastric, small intestine, colon)
* Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
* Positive hemoccult (per rectum)
* Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
* Taking oral benzodiazepines, barbiturates, or phenothiazines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02889393
Study Brief:
Protocol Section:
NCT02889393