search
Back to results

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

Primary Purpose

Short Bowel Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Growth Hormone
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Growth Hormone, TPN, Total Parenteral Nutrition, Glutamine, Short Bowel Syndrome, Increase in absorption of small bowel.

Eligibility Criteria

19 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

UNMC Group

Arm Description

Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).

Outcomes

Primary Outcome Measures

Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.
Evaluate the number of participants dosed at UNMC who had a reduction in the frequency of TPN infusions/week at 6 months compared to baseline

Secondary Outcome Measures

Change in Hydration Status
Number of participants who were able to maintain euvolemic status at 6 months post treatment
Change in Kidney Function at 6 Months Post Treatment
Number of participants with a significant change in kidney function at 6 months post treatment as compared to baseline.
Change in Liver Function at 6 Months Post Treatment
Number of participants with an improvement in their liver function ALT at 6 months post treatment as compared to baseline.
Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline
Number of participants who had a change in their ability to complete all activities of daily living by self at 6 months compared to baseline.

Full Information

First Posted
August 26, 2008
Last Updated
August 26, 2023
Sponsor
University of Nebraska
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00742157
Brief Title
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of Enrollment
Study Start Date
September 1, 2003 (Actual)
Primary Completion Date
October 20, 2008 (Actual)
Study Completion Date
October 20, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Growth Hormone, TPN, Total Parenteral Nutrition, Glutamine, Short Bowel Syndrome, Increase in absorption of small bowel.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UNMC Group
Arm Type
Other
Arm Description
Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Humatrope = Somatropin (rDNA origin) for injection
Intervention Description
dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
Primary Outcome Measure Information:
Title
Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.
Description
Evaluate the number of participants dosed at UNMC who had a reduction in the frequency of TPN infusions/week at 6 months compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Hydration Status
Description
Number of participants who were able to maintain euvolemic status at 6 months post treatment
Time Frame
6 months
Title
Change in Kidney Function at 6 Months Post Treatment
Description
Number of participants with a significant change in kidney function at 6 months post treatment as compared to baseline.
Time Frame
6 months
Title
Change in Liver Function at 6 Months Post Treatment
Description
Number of participants with an improvement in their liver function ALT at 6 months post treatment as compared to baseline.
Time Frame
6 months
Title
Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline
Description
Number of participants who had a change in their ability to complete all activities of daily living by self at 6 months compared to baseline.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fedja Rochling, MB, ChB
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs