Diet/Growth Factor Mechanisms of Gut Adaptation

Short Bowel Syndrome Clinical Trial

Official title:

Diet/Growth Factor Mechanisms of Gut Adaptation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067860
• Other study ID #: IRB00035030
• Secondary ID: R01DK055850
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2003
• Last updated: May 12, 2016
• Start date: October 1996
• Est. completion date: December 2006

Study information

• Verified date: May 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

• Parenteral nutrition-dependent adults with short gut syndrome.

• Patients must not have diabetes mellitus or active malignancy within the past 5 years.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Short Bowel Syndrome

Intervention

Drug:
• recombinant human growth hormone

Behavioral:
• diet modification

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,