Evaluation of Stool Collections to Measure Efficacy of PERT in Subjects With Exocrine Pancreatic Insufficiency

ABSTRACT Objective: The standard measure of pancreatic enzyme replacement therapy (PERT) efficacy in treating exocrine pancreatic insufficiency (EPI) is the coefficient of fat absorption (CFA). CFA measurement involves 72‐hour stool collection, which presents a logistical challenge because, although the test may be performed on an outpatient basis in clinical practice, hospitalization is needed if assurance of complete collection and 100% compliance is required, for example, in controlled situations such as clinical trials. Our aim was to investigate sparse stool sample collection as an alternative to complete 72‐hour collection for measurement of stool fat in subjects with EPI. Subjects and Methods: Prospective data analysis from a previously published, double‐blind, randomized, placebo‐controlled, 2‐period crossover trial in subjects ages 7 to 11 years with EPI caused by cystic fibrosis. Percentage fat (PF) data from sparse stool samples were compared with 72‐hour CFA values as a dichotomous variable (