drugset / Trial / NCT00067860

Diet/Growth Factor Mechanisms of Gut Adaptation

NCT00067860

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
1996-10
Primary completion
2006-12
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic

Indications