Journal article

Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-Controlled Double-Blind Trial

Catriona S Bradshaw, Marie Pirotta, Deborah De Guingand, Jane S Hocking, Anna N Morton, Suzanne M Garland, Glenda Fehler, Andrea Morrow, Sandra Walker, Lenka A Vodstrcil, Christopher K Fairley



BACKGROUND: To determine if oral metronidazole (MTZ-400 mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence. METHODS: Double-blind placebo-controlled parallel-group single-site study with balanced randomization (1:1:1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7-10 or ≥3 Amsel's criteria and NS = 4-10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV rec..

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Awarded by Australian National Health and Medical Research Council (NHMRC)

Funding Acknowledgements

This work was supported by the Australian National Health and Medical Research Council (NHMRC) Project Grant (APP454644). CSB and JSH were supported by research fellowships issued by the Australian National Health and Medical Research Council (APP 456164 and 566576 respectively). MP was supported by a Primary Health Care Research Evaluation and Development Mid-Career Fellowship, Department of Health and Aging. The NHMRC and Department of Health and Aging had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Medinova (Switzerland) provided the probiotic and placebo free of charge and had no commercial interest in the study. They did not provide funds or research support for the study. Specifically Medinova made recommendations for the duration of use the probiotic therapy in the study, but had no other role in study design, data collection and analysis or decision to publish. Medinova were given a draft of the manuscript to review but had no other role in preparation of the manuscript. CSB, MP, JSH, SMG, ANM, DG, GF, AM, SW, LAV, CKF do not have a commercial or other association that might pose a conflict of interest.