Factor VIIa, Recombinant |
NovoSeven |
Clinical Trial: Diet/Growth Factor Mechanisms of Gut Adaptation
This study is currently recruiting patients.
Purpose
This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Short Bowel Syndrome | Drug: recombinant human growth hormone Behavior: diet modification | Phase II |
MedlinePlus related topics: Digestive Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 30
Study start: October 1996
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
- Parenteral nutrition-dependent adults with short gut syndrome.
- Patients must not have diabetes mellitus or active malignancy within the past 5 years.
Location and Contact Information
Georgia
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Li H Gu, MD 404-727-5806 lgu@emory.edu
More Information
Record last reviewed: February 2005
Last Updated: February 7, 2005
Record first received: August 29, 2003
ClinicalTrials.gov Identifier: NCT00067860
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Factor VIIa, Recombinant (Drug Digest)
- NovoSeven (Drug Digest)

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