rHGH and Intestinal Permeability in Intestinal Failure
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Intestinal Failure
Intervention: Somatropin; Seven Day Food Diary; Blood Tests (standard of care); Fasting; Sugar Permeability Test; Urine Collection
Intervention description: Patients are given somatropin (growth hormone) for their short bowel syndrome for 28 days at a dose of 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily.; Subjects are asked to fill out a seven day food diary the week prior to their inpatient appointment, prior to receiving rHGH treatment for their short bowel syndrome. Subjects will be asked to repeat the use of a food diary after completing the administration of the growth hormone.; Blood tests are taken (standard of care) to evaluate the potential hepato-protective effects of improving intestinal barrier function on those receiving human growth hormone for short bowel syndrome. Per clinical protocol to test liver function i.e. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyl transpeptidase (GGT), Total Bilirubin). A complete blood count (CBC) with platelets (PLTS) and white-count differential (WBC with diff) is performed to check for anemia and infection. These tests will be taken at baseline (before fasting) and repeated again on the 28th day (last dose) of the growth hormone. Blood is also taken at clinical visit over the next two years (approximately every two months).; Eight hour overnight fast prior to being given sucralose, mannitol, lactulose, and sucrose. This is done at baseline (day one) and repeated again after the last dose of growth hormone and prior to sugar permeability urine tests.; Subject will be given 4 capsules of sucralose (250mg per capsule), 2.0 grams of mannitol, 7.5 grams of lactulose, and 40 grams of sucrose in 150 mL of water. This will be given on the second day of the study after an 8-hour overnight fast and repeated within 72 hours of the last dose of growth hormone.; Urine will be collected for the following five hours after subject has been given combination of sucralose, mannitol, lactulose, and sucrose to complete the intestinal sugar permeability test looking at urine ratio of lactulose to mannitol (L/M ratio). Tests include urinalysis (UA) and a blood urea nitrogen (BUN)/creatinine (Cr).
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Malabsorption

Summary:

      Patients who are being asked to participate in this study have a short small bowel and will
      be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is
      an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if
      taking this medication improves small bowel function by helping it to take in food,
      nutrients, vitamins and minerals. The investigators also believe that if the small bowel is
      absorbing food and nutrients better, liver function will improve as well. Therefore, liver
      function will also be monitored during the course of the study by performing blood tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be between the ages of 18 and 80

          -  Subjects can be male or female

          -  Subjects must have short bowel syndrome with <200cm of functional small bowel or have
             severe small bowel dysfunction mandating regular (at least two times per week)
             administration of total parenteral nutrition (TPN) and/or IV fluids.

          -  Subjects must have been dependent on TPN or IV fluids for 1 year, or are expected to
             be dependent on TPN or IV fluids for at least 1 yr.

          -  Subjects must be patients being seen in the Northwestern intestinal failure clinic

          -  Subjects must be willing to spend one night in the Clinical Research Center

          -  Subjects must be able to read, understand and be able to sign the study specific
             informed consent

        Exclusion Criteria:

          -  Subjects must be greater than or equal to 18 years of age, but less than or equal to
             80 years of age

          -  Infections requiring antibiotic therapy within one week of starting the study

          -  Subjects must not have evidence of an ongoing malignancy for two years

          -  Subjects must not have history of antibiotic use within one week of initiating the
             study. Subjects may enroll in the study as long as Visit 1 is at least one week from
             the last dose of antibiotics.

          -  Subjects that have evidence of acute critical illness due to complications following
             open heart or abdominal surgery, multiple accidental trauma, or acute respiratory
             failure

          -  Subjects with known liver disease, positive hepatitis B virus (HBV), or hepatitis C
             virus (HCV) serology

          -  Subjects unwilling to abstain from alcohol 7 days prior to and during the 28 days of
             Zorbtive® therapy, until completion of Visit 2

          -  Subjects with a known sensitivity to Benzyl Alcohol

          -  Subjects with a known sensitivity to growth hormone

          -  Female subjects that are unable or unwilling to use effective, acceptable birth
             control methods throughout the study and for up to 6 months after completing treatment
             with Zorbtive therapy

          -  Female subject with a positive pregnancy test