The safety of whey protein concentrate derived from the milk of cows immunized against Clostridium difficile.
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.
Young
Karen W H
KW
Cantox Health Sciences International, 2233 Argentia Road, Suite 308, Mississauga, ON, Canada L5N 2X7. kyoung@cantox.com
Munro
Ian C
IC
Taylor
Steve L
SL
Veldkamp
Peter
P
van Dissel
Jaap T
JT
D000368:Aged; D000818:Animals; D001426:Bacterial Proteins / Q000276:immunology*; D001427:Bacterial Toxins / Q000276:immunology*; D002417:Cattle; D016360:Clostridioides difficile / Q000276:immunology*; D003015:Clostridium Infections / Q000276:immunology / Q000517:prevention & control / Q000628:therapy*; D003257:Consumer Product Safety; D004768:Enterotoxins / Q000276:immunology*; D005260:Female; D006801:Humans; D007114:Immunization; D007070:Immunoglobulin A / Q000032:analysis / Q000276:immunology; D007074:Immunoglobulin G / Q000032:analysis / Q000276:immunology; D007167:Immunotherapy; D008297:Male; D008892:Milk; D008894:Milk Proteins / Q000032:analysis / Q000627:therapeutic use*; D000067816:Whey Proteins
D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D008894:Milk Proteins; D000067816:Whey Proteins; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile