Teduglutide for Enterocutaneous Fistula (ECF)
Condition: Postoperative Fistula
MeSH terms: Intestinal Fistula; Fistula
Intervention: Teduglutide; Standard of Care
Intervention description: Daily 0.05 mg/kg Teduglutide administered subcutaneously.; The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion.
Intervention MeSH terms: Teduglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Teduglutide is safe and feasible to be
      given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug
      will be well tolerated and will improve the volume of daily ECF output as well as improve the
      functional quality of life.
    

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