title: A randomized, double-blind study comparing Clostridium difficile immune whey and metronidazole for recurrent Clostridium difficile-associated diarrhoea: efficacy and safety data of a prematurely interrupted trial.
abstract: A prospective, randomized, double-blind study was designed to compare Clostridium difficile immune whey (CDIW) with metronidazole for treatment of laboratory-confirmed, recurrent, mild to moderate episodes of Clostridium difficile-associated diarrhoea (CDAD). CDIW was manufactured by immunization of cows in their gestation period with inactivated C. difficile vaccine. The resulting colostrum was processed, immunoglubulins were concentrated and the end-product containing high titres of C. difficile immunoglobulin was used as CDIW. 20 patients received metronidazole at a dosage of 400 mg t.i.d. and 18 patients CDIW 200 ml t.i.d. The study was interrupted early because of the bankruptcy of the sponsor. After 14 d of treatment, all 20 (100%) of 20 patients had responded to metronidazole therapy, compared with 16 (89%) of 18 who had received CDIW. 70 d after the beginning of treatment, sustained responses were observed in 11 (55%) of 20 patients receiving metronidazole and 10 (56%) of 18 patients treated with CDIW. In this preliminary study CDIW was as effective as metronidazole in the prevention of CDAD recurrences and it was well tolerated.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Finland. eero.mattila@hus.fi
authors.forename: Eero
authors.initials: E
authors.lastname: Mattila
authors.forename: Veli-Jukka
authors.initials: VJ
authors.lastname: Anttila
authors.forename: Markku
authors.initials: M
authors.lastname: Broas
authors.forename: Harri
authors.initials: H
authors.lastname: Marttila
authors.forename: Paula
authors.initials: P
authors.lastname: Poukka
authors.forename: Kaisa
authors.initials: K
authors.lastname: Kuusisto
authors.forename: Liana
authors.initials: L
authors.lastname: Pusa
authors.forename: Kari
authors.initials: K
authors.lastname: Sammalkorpi
authors.forename: Jan
authors.initials: J
authors.lastname: Dabek
authors.forename: Olli-Pekka
authors.initials: OP
authors.lastname: Koivurova
authors.forename: Markku
authors.initials: M
authors.lastname: Vähätalo
authors.forename: Veikko
authors.initials: V
authors.lastname: Moilanen
authors.forename: Tom
authors.initials: T
authors.lastname: Widenius
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002417:Cattle; D016360:Clostridioides difficile / Q000276:immunology*; D003015:Clostridium Infections / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control; D003967:Diarrhea / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007114:Immunization; D007167:Immunotherapy; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D008894:Milk Proteins / Q000008:administration & dosage / Q000276:immunology*; D016896:Treatment Outcome; D000067816:Whey Proteins; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008894:Milk Proteins; D000067816:Whey Proteins; D008795:Metronidazole