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Diet/Growth Factor Mechanisms of Gut Adaptation - Article


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Ice Cream Diet


Clinical Trial: Diet/Growth Factor Mechanisms of Gut Adaptation

This study is currently recruiting patients.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

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.

Condition Treatment or Intervention Phase
Short Bowel Syndrome
 Drug: recombinant human growth hormone
 Behavior: diet modification
Phase II

MedlinePlus related topics:  Digestive Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  30

Study start: October 1996

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

  • Parenteral nutrition-dependent adults with short gut syndrome.
  • Patients must not have diabetes mellitus or active malignancy within the past 5 years.

Location and Contact Information


Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting
Thomas R Ziegler, MD  404-727-7351    tzieg01@emory.edu 
Li H Gu, MD  404-727-5806    lgu@emory.edu 

More Information

Study ID Numbers:  DGFMGA
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  August 29, 2003
ClinicalTrials.gov Identifier:  NCT00067860
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 6, 2008



Page Updated: June 20, 2006
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