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Diet/Growth Factor Mechanisms of Gut Adaptation



Diet/Growth Factor Mechanisms of Gut Adaptation

For Condition: Short Bowel Syndrome
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechansisms 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 expresssion 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: - Parenteral nutrition-dependent adults with short gut syndrome. - Patients must not have diabetes mellitus or active malignancy within the past 5 years.
Total Enrollment: 30

Location and Contact Information:

Emory University School of Medicine *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Thomas  Ziegler 404-727-7351


Additional Information:
Study ID Numbers:
  DGFMGA; 
Study Start Date: October 1996
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067860

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1. Diet/Growth Factor Mechanisms of Gut Adaptation

2. Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome

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