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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00067860 |
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 | Intervention | Phase |
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Short Bowel Syndrome |
Drug: recombinant human growth hormone Behavioral: diet modification |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Diet/Growth Factor Mechanisms of Gut Adaptation |
Estimated Enrollment: | 30 |
Study Start Date: | October 1996 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | DGFMGA DK55850, DK55850 |
Study First Received: | August 29, 2003 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00067860 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Postoperative Complications Gastrointestinal Diseases Mitogens |
Malabsorption Syndromes Short Bowel Syndrome Intestinal Diseases Hormones |
Disease Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Mitosis Modulators Short Bowel Syndrome Intestinal Diseases Pharmacologic Actions |
Digestive System Diseases Pathologic Processes Postoperative Complications Syndrome Malabsorption Syndromes Mitogens |