title: Bovine antibody-enriched whey to aid in the prevention of a relapse of Clostridium difficile-associated diarrhoea: preclinical and preliminary clinical data.
abstract: 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.
authors.affiliation: Department 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.
authors.forename: Jaap T
authors.initials: JT
authors.lastname: van Dissel
authors.affiliation: Department 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.
authors.forename: Nanda
authors.initials: N
authors.lastname: de Groot
authors.affiliation: Department 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.
authors.forename: Charles Mh
authors.initials: CM
authors.lastname: Hensgens
authors.affiliation: Department 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.
authors.forename: Sandra
authors.initials: S
authors.lastname: Numan
authors.affiliation: Department 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.
authors.forename: Ed J
authors.initials: EJ
authors.lastname: Kuijper
authors.affiliation: Department 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.
authors.forename: Peter
authors.initials: P
authors.lastname: Veldkamp
authors.affiliation: Department 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.
authors.forename: Jan
authors.initials: J
authors.lastname: van 't Wout
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000627:therapeutic use*; D002417:Cattle; D016360:Clostridioides difficile / Q000276:immunology*; D003015:Clostridium Infections / Q000517:prevention & control*; D015331:Cohort Studies; D006224:Cricetinae; D003967:Diarrhea / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D010865:Pilot Projects; D011446:Prospective Studies
chemical_list: D000907:Antibodies, Bacterial