The current """"""""gold-standard"""""""" for quantitative assessment of steatorrhea, 72-h stool fat, is universally recommended in evaluation of malabsorption but vastly under-utilized because it is tedious and difficult to perform. We propose a novel approach for direct measurement of steatorrhea from all causes which eliminates the limitations of the 72-h stool test while retaining its important features. Our approach is based on administration of 1,3--[13C]distearyl, 2-oleolyl glycerol and the nonabsorbable marker DyCI3 with a high fat meal followed by analysis of a single stool. The test is expected to be sensitive to steatorrhea of maldigestion and fatty acid malabsorption, cost effective, and to provide results that are highly correlated with 72-h stool fat in individual patients. During Phase I, we demonstrated the feasibility of the approach by showing that Dy is quantitatively excreted and follows the same excretion kinetics as 13C- labeled triglyceride. During Phase II, we will study details of the approach leading to a practical test for clinical use. We will demonstrate that labeled triglyceride absorption is reproducible, accurately reflects the degree of steatorrhea in individual patients, and has excellent diagnostic sensitivity/specificity. The developed test kit and analytical services will be marketed through BioChemAnalysis Corporation.

Proposed Commercial Applications

This research will lead to the availability of a test kit and procedure for accurate quantitation of steatorrhea from all causes and requires collection of only a single stool. Because the procedure highly reproducible, accurate and relatively simple to use it will be applicable to clinical diagnostic use as well as use in research.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK048190-02A1
Application #
2016837
Study Section
Special Emphasis Panel (ZRG2-PSF (03))
Project Start
1994-09-30
Project End
2000-09-29
Budget Start
1997-09-30
Budget End
1998-09-29
Support Year
2
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Biochemanalysis Corporation
Department
Type
DUNS #
City
Chicago
State
IL
Country
United States
Zip Code
60612
Borowitz, Drucy; Durie, Peter R; Clarke, Lane L et al. (2005) Gastrointestinal outcomes and confounders in cystic fibrosis. J Pediatr Gastroenterol Nutr 41:273-85
Schuette, Sally A; Janghorbani, Morteza; Cohen, Mitchell B et al. (2003) Effect of triglyceride structure on fecal excretion of 13C-labeled triglycerides. J Am Coll Nutr 22:511-8