Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) - Full Text View

Sponsor:	University of Nebraska
Collaborator:	Eli Lilly and Company
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00742157

Purpose

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.

Condition	Intervention	Phase
Short Bowel Syndrome	Drug: Growth Hormone	Phase IV

Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Glutamine Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	March 2003
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	19 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742157

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

Eli Lilly and Company

Investigators

Principal Investigator:

Fedja Rochling, MB ChB

University of Nebraska

More Information

No publications provided

Responsible Party:	Fedja Rochling, MB ChB, University of Nebraska Medical Center
ClinicalTrials.gov Identifier:	NCT00742157 History of Changes
Other Study ID Numbers:	061-03
Study First Received:	August 26, 2008
Last Updated:	August 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Nebraska:

Growth Hormone
TPN
Total Parenteral Nutrition

Glutamine
Short Bowel Syndrome
Increase in absorption of small bowel.

Additional relevant MeSH terms:

Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications

Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012