Clinical Trial: Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD

Brief Summary: This study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a wasting syndrome) improve their nutritional status and gain weight. The medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the nutritional status of cachexic patients with advanced stages of COPD.

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome: The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months. [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Medical University of South Carolina

Dates:
Date Received: February 6, 2014
Date Started: December 2013
Date Completion:
Last Updated: September 1, 2016
Last Verified: August 2013