Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel … (NCT00742157) | Clinical Trial Compass
TerminatedPhase 4
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
Stopped: Lack of Enrollment
United States5 participantsStarted 2003-09-01
Plain-language 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.
Who can participate
Age range19 Years – 78 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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…
What they're measuring
1
Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.