The safety of whey protein concentrate derived from the milk of cows immunized against Clostridium difficile

Karen W.H. Young, Ian C. Munro, Steve L. Taylor, Peter Veldkamp, Jaap T. van Dissel

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

A whey protein concentrate prepared from the milk of cows that have been immunized against Clostridium difficile (C. difficile) and its toxins, toxin A and toxin B, is produced for use as a medical food for the dietary management of patients with C. difficile-associated diarrhea (CDAD) to prevent a relapse of the infection. The safety of anti-C. difficile whey protein concentrate (anti-CD WPC) is supported by analytical data comparing the composition of raw milk from immunized cows versus that from non-immunized cows, and the composition of anti-CD WPC versus that of regular whey protein concentrate. Additionally, a prospective clinical study was conducted in 77 patients with CDAD to demonstrate the safety of consuming anti-CD WPC to prevent relapse of the infection. This study, which included adverse event monitoring, physical examinations, and extensive hematological and biochemical assessments, showed that anti-CD WPC is safe to consume by patients with CDAD. The available analytical and clinical evidence demonstrate that anti-CD WPC is safe for use by individuals with CDAD, under the described conditions of use.

Original languageEnglish (US)
Pages (from-to)317-326
Number of pages10
JournalRegulatory Toxicology and Pharmacology
Volume47
Issue number3
DOIs
StatePublished - Apr 2007

Keywords

  • Bovine
  • Clostridium difficile
  • Hyperimmune milk
  • Immunoglobulin
  • Whey protein concentrate

ASJC Scopus subject areas

  • Toxicology

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