title: [Recurrence of Clostridium difficile-associated diarrhoea prevented by the administration of a whey concentrate from specifically immunised cows; prospective study].
abstract: OBJECTIVE
  To try to prevent recurrences of Clostridium difficile-associated diarrhoea (CDAD) by treatment with a specific neutralising secretory IgA-enriched whey-protein concentrate (40%) made from the milk of cows immunised with C. difficile and its toxins.
  
  
  METHODS
  Prospective, non-blinded, clinical cohort study.
  
  
  METHODS
  In 2005-2006, 100 consecutive patients with CDAD received the whey concentrate for 2 weeks after completion of standard antibiotic therapy. For a period of 60 days after the start of the administration, the safety and preliminary efficacy of the whey concentrate were evaluated by means of a diary, blood determinations, active surveillance for adverse events, and the recurrence of CDAD.
  
  
  RESULTS
  The whey concentrate was well tolerated and no safety issues were raised. Eleven out of 109 episodes (10%) were followed by a recurrence. After completion of the whey concentrate therapy, a positive test for faecal toxins or culture of C. difficile was predictive for the recurrence of CDAD (relative risk: 8.2 (95% CI: 1.04-64), and 4.7 (95% CI: 0.5-47), respectively). A positive faeces toxin during administration of the whey concentrate was also associated with an early recurrence of CDAD.
  
  
  CONCLUSIONS
  Compared to historical and contemporary findings in control groups, the whey concentrate appeared to reduce the recurrence of CDAD by about 50%. However, the standard dose of the whey concentrate was probably not sufficient to fully neutralise the C. difficile toxins in faeces in all episodes.
authors.affiliation: Leids Universitair Medisch Centrum, Postbus 9600, 2300 RC Leiden.
authors.forename: M P
authors.initials: MP
authors.lastname: Bauer
authors.forename: S C
authors.initials: SC
authors.lastname: Numan-Ruberg
authors.forename: O W
authors.initials: OW
authors.lastname: Bredewold
authors.forename: E J
authors.initials: EJ
authors.lastname: Kuijper
authors.forename: E A N M
authors.initials: EA
authors.lastname: Mooi-Kokenberg
authors.forename: S B
authors.initials: SB
authors.lastname: Debast
authors.forename: J T
authors.initials: JT
authors.lastname: van Dissel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002417:Cattle; D016360:Clostridioides difficile / Q000276:immunology*; D003015:Clostridium Infections / Q000276:immunology* / Q000517:prevention & control*; D015331:Cohort Studies; D003257:Consumer Product Safety; D003967:Diarrhea / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007114:Immunization; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D008894:Milk Proteins / Q000627:therapeutic use*; D011446:Prospective Studies; D000067816:Whey Proteins
chemical_list: D008894:Milk Proteins; D000067816:Whey Proteins