20
Participants
Start Date
November 30, 2015
Primary Completion Date
March 31, 2017
Study Completion Date
March 2, 2017
Medical Food
Serum-derived bovine immunoglobulin protein isolate will be supplied by EnteraHealth. The product is manufactured in accordance with Good Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) guidelines for medical food ingredients (21 CFR Part 110). Serum-derived bovine immunoglobulin protein isolate (SBI) is generally recognized as safe (GRAS). The FDA has reviewed the safety dossier for SBI as a medical food product.
Placebo
Childrens Hospital, New Orleans
Collaborators (1)
Entera Health, Inc
INDUSTRY
Louisiana State University Health Sciences Center in New Orleans
OTHER