Status:
TERMINATED
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
19-78 years
Phase:
PHASE4
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/o...
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 dysfunctio...
Eligibility Criteria
Inclusion
- Be male or female between 19 and 78 years of age, inclusive
- Have a diagnosis of SBS and 1 or more of the following characteristics:
- Dependent upon TPN and/or IV fluids
- Unable to receive TPN because of a documented history of complications associated with the long-term parenteral infusions (e.g. lack of venous access, multiple septic events, progressive liver dysfunction while on TPN, etc)
- A documented remnant bowel anatomy that is inconsistent with adequately supporting life without parenteral support (e.g. \< 70 cm of healthy small intestine and a portion of colon, or less than 150 cm in patients with no colon)
- A documented history of diarrhea and/or malabsorption that has significantly compromised the patient's nutritional and hydration status (e.g. significant weight loss - 5% over 1 month or 10% over 6 months, or a serum albumin \< 3.5 g/dl, documented nutrient deficiencies, documented episodes of dehydration, etc).
- Is able to eat at least some (\>500 calories) of solid food on a regular basis or tolerate at least some (\>500 calories) of an enteral feeding formula
- Have stable liver and renal function
- For patients with known hypertension and other cardiovascular disorders, be both compensated and stabilized on a regular therapeutic regimen
- For women participating in the study, manifest or give assent to 1 of the following criteria to ensure that the patient does not become pregnant during the study:
- The patient must be surgically sterile or demonstrably postmenopausal.
- Any patient capable of becoming pregnant must have a negative urine pregnancy test and must agree to practice a method of contraception documented to have at least 90% reliability throughout the treatment period.
- Have the ability to understand the requirements of the study, to provide written Informed Consent, and to abide by the study restrictions and agree to complete the required assessments in the Follow-up Period
Exclusion
- Be pregnant or lactating
- Have a history of mental deficiency or illness that might compromise compliance with the requirements of the study
- Have clinically serious neurological dysfunction
- Have hypoxemic pulmonary diseases (i.e., resting pAO2 \< 75 torr)
- Have unstable ischemic heart disease or uncompensated cardiac failure
- Have participated in any study involving an investigations drug within 30 days prior to entry into this trial.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00742157
Start Date
September 1 2003
End Date
October 20 2008
Last Update
September 8 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198