Phase 4
N=15
rHGH and Intestinal Permeability in Intestinal Failure
Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01380366 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
Mar 2014
Primary outcome: Primary: To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®). — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Somatropin (Drug); Seven Day Food Diary (Procedure); Blood Tests (standard of care) (Procedure); Fasting (Other); Sugar Permeability Test (Other); Urine Collection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®). |
7 | — |
| SECONDARY To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®. |
7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01380366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.