Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Evaluation of the Long-term Efficacy and Safety of a Standardized Regimen of Growth Hormone, Glutamine and a Modified Diet in the Treatment of Patients With Short Bowel Syndrome|
- Evaluate the change in volume and frequency of TPN infusions at 6 months compared to baseline following 3.5 - 8 weeks of treatment with GH+GLN+Diet, followed by the individualized oral diet and enteral GLN over a 6-month period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Utilize pooled data from previously studied patients (high-dose GH) and current patients (lower dose GH). Compare changes in nutritional status, hydration status and kidney function, liver function and physical functioning capacity in patients with SBS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2003|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
No Intervention: UNMC Group
Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).
Drug: Growth Hormone
dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
Other Name: Humatrope = Somatropin (rDNA origin) for injection
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Fedja Rochling, MB ChB||University of Nebraska|