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

被引:97
作者
van Dissel, JT [1 ]
de Groot, N
Hensgens, CMH
Numan, S
Kuijper, EJ
Veldkamp, P
van't Wout, J
机构
[1] Leiden Univ, Med Ctr, Ctr Infect Dis, Dept Infect Dis, Leiden, Netherlands
[2] Leiden Univ, Med Ctr, Ctr Infect Dis, Dept Med Microbiol, Leiden, Netherlands
[3] MucoVax BV, Leiden, Netherlands
[4] Univ Pittsburgh, Dept Med, Div Infect Dis, Pittsburgh, PA USA
[5] Bronovo Hosp, Dept Internal Med, The Hague, Netherlands
关键词
D O I
10.1099/jmm.0.45773-0
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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 (110 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.
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页码:197 / 205
页数:9
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