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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。TheraCLEC-Total含有三种活性酶成分：TheraCLEC-脂肪酶，蛋白酶和淀粉酶。预期用于治疗部分或完全外分泌胰腺功能不全引起的吸收不良。TheraCLEC-Total旨在提供一种强效稳定的胰酶制剂，可使患者服用较小剂量。酶来源于受控微生物菌株的发酵并从其纯化。脂肪酶和蛋白酶组分被结晶以提供稳定性，并且脂肪酶也被交联以进一步稳定酶。这三种酶组分以胶囊形式提供，用于临床试验中的测试。

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.