rHGH and Intestinal Permeability in Intestinal Failure

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.

Conditions

• Short Bowel Syndrome

Interventions

DRUG

Somatropin

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.

PROCEDURE

Seven Day Food Diary

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.

PROCEDURE

Blood Tests (standard of care)

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).

OTHER

Fasting

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.

OTHER

Sugar Permeability Test

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.

OTHER

Urine Collection

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).

Sponsors & Collaborators

• Northwestern Memorial Hospital

  collaborator OTHER

• EMD Serono

  collaborator INDUSTRY

• Northwestern University

  lead OTHER

Principal Investigators

• Jonathan Fryer, MD · Northwestern Memorial Hospital, Northwestern University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2011-02-28

Completion

2015-02-28

Countries

• United States

Study Locations