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OpenTrials
Completed

NCT Number: NCT00067860

Diet/Growth Factor Mechanisms of Gut Adaptation

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human growth hormone

Drug

Diet modification

Behavioral

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
1996
Primary completion
2006
Study completion
2006
First posted
Sep 1, 2003
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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