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.
Phase:
Phase 2
Details
Lead Sponsor:
Emory University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)