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. Altus Biologics has developed a pancreatic enzyme replacement product, TheraCLEC -Total, which consists of lipase, protease and amylase, intended to aid in the digestion of fats, proteins and carbohydrates in pancreatic insufficient subjects. This is a double blind, multicenter study of TheraCLEC -Total in pancreatic-insufficient subjects with cystic fibrosis (CF). The study plans to enroll 140 subjects. The study is separated into four periods; screening period, baseline period, treatment period, and follow up. The baseline and treatment periods require inpatient care at a clinical research center (CRC). Pancreatic insufficiency (PI) is present in greater than 85% of all patients with CF by the age of 8 to 9 years.1 Both the abnormal amounts and viscosity of mucus in CF patients impede the secretion of sufficient pancreatic enzymes. Uncorrected maldigestion and malabsorption lead to malnutrition, failure to gain or maintain weight, decreased growth, and worsening of chronic suppurative lung disease.2,3,4 CF patients with PI typically absorb less than 60% of dietary fat.4,5 Usual treatment of PI includes coated or uncoated enzyme supplementation containing porcine pancreatic enzyme concentrate, which includes lipases, proteases and amylases. Currently, all such enzyme replacement products are given orally with meals and snacks at a dose level titrated to clinical symptoms, and in some instances fat absorption measures. As these products pass through the low pH environment of the stomach, enzyme activity rapidly diminishes. Therefore large quantities of enzyme concentrate have been required to ensure that active enzyme is present in the proximal intestine to treat PI.
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