A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO EVALUATE INTRADUODENAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The ultimate expectation of this study and of the continued studies of feedback inhibition of pancreatic secretion in our laboratory is to develop a potent pancreatic enzyme preparation which can release its compounds consistently into the duodenum. Delivery of pancreatic lipase, amylase and protease will be evaluated utilizing an intestinal aspiration methodology that this laboratory has utilized successfully on numerous occasions. Twelve subjects with chronic pancreatitis will be studied, all of whom will have excretion of elevated amounts of fecal fat- pancreatic insufficiency. The delivery of lipase, amylase and protease will be compared in a fasted and fed state with and without the addition of pancreatic enzymes. This study will demonstrate the efficacy of PANCREASE MT. This technique is a necessity for the evaluation of all pancreatic enzyme preparations whether it is for the treatment of fat malabsorption or abdominal pain.