NCT00067860

Diet/Growth Factor Mechanisms of Gut Adaptation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	recombinant human growth hormone
BEHAVIORAL	diet modification

Timeline

• Start date: 1996-10-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2003-09-01
• Last updated: 2016-05-16

Locations

1 site across 1 country: United States