A PHASE II, RANDOMIZED, DOUBLE BLIND, PARALLEL DOSE STUDY OF ORAL THERACLEC-TOTA

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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. TheraCLEC-Total contains three active enzyme ingredients: TheraCLEC-lipase, protease and amylase. It is intended for the treatment of malabsorption due to partial or complete exocrine pancreatic insufficiency. ThereaCLEC-Total is designed to provide a potent stable formulation of pancreatic enzymes that may allow patients to take smaller doses. The enzymes are sourced and purified from fermentation of controlled microbial strains. The lipase and protease components are crystallized to provide stability and the lipase is also crosslinked to further stabilize the enzyme. The three enzyme components are provided in capsule form for testing in clinical trials.