Clinical trial NCT00742157
Conditions: Short Bowel Syndrome
Keywords: Growth Hormone TPN Total Parenteral Nutrition Glutamine Short Bowel Syndrome Increase in absorption of small bowel.
Sponsor: University of Nebraska
Start date: 2003-09-01; Completion date: 2008-10-20
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
Long-term total parenteral nutrition (TPN) is a supportive, rather than curative, therapy for patients with severe short bowel syndrome (SBS). Because of the complications (liver and kidney dysfunction, bone demineralization, nutrient deficiencies, catheter sepsis) and costs (\>$100,000/ patient/year) associated with this therapy, researchers have attempted to identify a safe, cost-effective alternative treatment modality. Various surgical procedures (including bowel transplantation) have been explored; however, these options currently offer limited clinical efficacy and significant morbidity and mortality. In contrast, a non-invasive therapy utilizing a growth factor (growth hormone - GH) and a bowel-specific nutrient (glutamine - GLN) in combination with an individualized oral diet (GH+GLN+Diet) has recently been shown to significantly enhance nutrient absorption and eliminate or reduce TPN requirements in patients with severe SBS.

This open-labeled, single-center trial with a total enrollment of 30 patients with severe SBS will examine the safety and effectiveness of a lower dose (0.05 mg/kg/day) of growth hormone. Thirty-two subjects have previously been studied at the Nutritional Restart Center in Massachusetts utilizing a higher dose (0.1 mg/kg/day) of growth hormone and identical treatment parameters as described in this protocol. The University of Nebraska Medical Center and the Nutritional Restart Center have agreed to pool the data from both studies and analyze the data according to the same primary efficacy variable. Subjects recruited to the lower-dose growth hormone group will be matched, using specific clinical criteria, to patients in the higher dose growth hormone group. The primary efficacy variable will be the change in volume of TPN infusion/week and frequency of TPN infusions/week at 6 months following discharge compared to baseline.

After a 3 day, baseline evaluation at The Nebraska Medical Center to determine pre-treatment TPN requirements and to assess the specific indices of nutritional and hydration status and kidney and liver function, and physical functioning capacity, patients will begin to receive lower dose GH (0.05 mg/kg/day) in combination with GLN (30 grams/day, orally) and the individualized oral/enteral diet. Treatment will last for a minimum of 23 days and a maximum of 54 days. Duration of treatment will be tailored to the patients' individual needs (e.g., understanding and acceptance of the modified diet, successful weaning of TPN). Patients may return to their home to continue receiving the GH treatment, provided they are tolerating the GH injections and understand how to properly administer the injections.

Arms: arm 1: Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).
Interventions: intervention 1: Growth Hormone
Intervention descriptions: intervention 1: dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.

Protocol documents: