Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea
Completed · Phase 4
Conditions studied: Cystic Fibrosis, Pancreatic Insufficiency
In brief
\*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.
Key facts
- Study ID
- NCT00572975
- Run by
- Children's Hospital of Philadelphia
- People needed
- 9
- Starts
- 2006-08-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2008-09-30
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim.
- Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1< 200 mg/g stool.
You may not qualify if…
- Subjects will be ineligible if they have an FEV1 % predicted of < 40%, a history of fibrosing colonopathy or any significant bowel resection (>10 cm) with the exception of a routine, uncomplicated appendectomy.
- Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study.
- Subjects with significant liver disease, or significant developmental delay will also be excluded.
- Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red.
- Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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