Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis
Condition: Bacterial Vaginosis; Bacterial Vaginitis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Vaginitis
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether supplementation of standard antibiotic
      therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences
      recurrence of bacterial vaginosis/vaginitis.
    

Detailed description: 
      Bacterial vaginosis is the most common vaginal infection in women of reproductive age. This
      condition is caused by an overgrowth of anaerobic bacteria with concomitant reductions in
      Lactobacillus populations in the vagina, i.e. disruption of the vaginal microbiota. Aerobic
      vaginitis is related to the suppression of lactobacilli by various aerobic bacteria, mostly
      originating from the anal microbiota.

      Previous open-label study confirmed that probiotic strains - Lactobacillus fermentum 57A,
      Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C given orally to women with
      intermediate/abnormal vaginal flora and no clinical symptoms had the ability to colonize
      rectum and vagina and contributed to the maintenance of pH level and Nugent score. The
      colonisation of women with tested strains had been confirmed by microbiological and molecular
      methods.

      The purpose of this multicentre, randomized study was to investigate whether the use of a
      probiotic preparation containing Lactobacillus fermentum 57A, Lactobacillus plantarum 57B,
      and Lactobacillus gasseri 57C together with standard treatment for bacterial
      vaginosis/vaginitis could reduce the recurrence rates of these conditions, as assessed using
      clinical and microbiological criteria, in comparison with standard treatment alone. The study
      took place between March 2009 and February 2012 in nine private out-patient gynaecological
      clinics in the Krakow area and Katowice (Silesia) in Poland. It was conducted in accordance
      with the original protocol and according to ICH-GCP requirements. The duration of subject's
      participation in the trial was approximately 5-6 months (follow-up visit included). As the
      trial did not concern medicinal product but the foodstuff (dietary supplement) it did not
      require Authority approval but was only subject to relevant Ethics Committee approval.

      Women with history of recurrent bacterial vaginosis/vaginitis, aged 18 - 50 years, who
      complied with inclusion and exclusion criteria and who signed informed consent form were
      enrolled and randomized into one of the study groups.

      Efficacy parameters were based on the evaluation of clinical symptoms during gynaecological
      examinations, as well as the determination of vaginal pH, Nugent score, total Lactobacillus
      counts and presence/numbers of vaginal pathogens in cultures from vaginal swabs collected at
      each visit. Data obtained at the third-fifth visits were compared with those obtained at the
      first visit. Clinical samples were transported to central laboratory for further analysis.

      Safety parameters were analysed using information recorded in 'patient's diaries' throughout
      the study period, as well as the investigator's assessments at each visit.
    

Intervention name(s): probiotic; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): antibiotic plus probiotic; antibiotic plus placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care