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Bovine antibody-enriched whey to aid in the prevention of a relapse of Clostridium difficile-associated diarrhoea: preclinical and preliminary clinical data

^1,3Department of Infectious Diseases¹ and Department of Medical Microbiology³, Center for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands ²MucoVax bv, Niels Bohrweg 11–13, Leiden, The Netherlands ⁴Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, USA ⁵Department of Internal Medicine, Bronovo Hospital, Bronovolaan 5, The Hague, The Netherlands

Correspondence Jaap T. van Dissel j.t.van_dissel{at}lumc.nl

Received June 11, 2004
Accepted November 4, 2004

In a pilot study, the feasibility of immune whey protein concentrate (40 %; immune WPC-40) to aid the prevention of relapse of Clostridium difficile diarrhoea was evaluated. Immune WPC-40 was made from milk after immunization of Holstein–Frisian cows with C. difficile-inactivated toxins and killed whole-cell C. difficile. Immune WPC-40 contained a high concentration of specific sIgA antibodies, and was effective in neutralizing the cytotoxic effect of C. difficile toxins in cell assays in vitro. Immune WPC-40 conferred protection from otherwise lethal C. difficile-associated caecitis in hamsters. To obtain preliminary data in humans, 16 patients (10 male; median 57 years) with toxin- and culture-confirmed C. difficile diarrhoea were enrolled in an uncontrolled cohort study. Nine had a history of relapsing C. difficile diarrhoea. After completion of standard antibiotic treatment, the patients received immune WPC-40 TID for 2 weeks; it was well tolerated and no treatment-related adverse effects were observed. In all but one case, C. difficile toxins had disappeared from the faeces upon completion of treatment. During a follow-up period of median 333 days (range 35 days to 1 year), none of the patients had suffered another episode of C. difficile diarrhoea. These preliminary data suggest that immune whey protein concentrate-40 may be of help in the prevention of relapse of C. difficile diarrhoea.

Abbreviations: CDAD, C. difficile-associated diarrhoea; WPC, whey protein concentrate.

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