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Sponsors and Collaborators: |
Children's Hospital of Philadelphia Solvay Pharmaceuticals |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00572975 |
*The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.
Condition | Intervention | Phase |
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Cystic Fibrosis Pancreatic Insufficiency |
Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea |
Enrollment: | 9 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)
Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption. in breakfast shake x1 |
Prior to each study visit all subjects will be required to:
Ages Eligible for Study: | 8 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104-4399 |
Principal Investigator: | Maria Mascarenhas, M.D. | Children's Hospital of Philadelphia |
Responsible Party: | The Children's Hospital of Philadelphia ( Maria R. Mascarenhas, M.D. ) |
Study ID Numbers: | 2004-5-3733 |
Study First Received: | December 11, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00572975 |
Health Authority: | United States: Institutional Review Board |
New diagnostic test for Cystic Fibrosis. |
Metabolic Diseases Fibrosis Gastrointestinal Diseases Intestinal Diseases Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn |
Lung Diseases Malabsorption Syndromes Pancreatic Diseases Infant, Newborn, Diseases Metabolic disorder Cystic fibrosis Exocrine Pancreatic Insufficiency Steatorrhea |
Pathologic Processes |