Assessment of a PERT-free Nutritional Therapeutic Delivery System for

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional supplement for blood lipid levels, safety and tolerability compared to a standard of care nutritional supplement used concomitantly with PERT. The study hypothesis is that the PERT-free nutritional supplement will be equivalent to, or superior to, a standardized nutritional shake with regard to fat absorption, as indicated by blood lipid (triglyceride) levels while maintaining tolerability and safety without the use of PERT. The objective is to evaluate efficacy, safety, and tolerability of a "PERT-free" nutritional shake compared to a standard nutritional shake used concomitantly with PERT. Measurements include components of a standard lipid blood panel (triglycerides, cholesterol, HDL cholesterol, LDL cholesterol, and VLDL cholesterol), absorption of fat-soluble vitamins (vitamin D) and symptoms associated with EPI. Other objectives include evaluating palatability and patients' impressions of the products. ;

Study Design

Related Conditions & MeSH terms

Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis

Clinical Trial Details

NCT number	NCT04966897
Study type	Interventional
Source	GlycosBio, Inc.
Contact
Status	Completed
Phase	N/A
Start date	August 31, 2018
Completion date	September 30, 2019

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Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms