NCT01993524

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

Efficacy and Safety Assessment of prOVag Dietary Supplement in Recurrent Bacterial Vaginitis. Multi-centre, Randomized, Double-blind, Placebo-controlled Clinical Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: IBSS Biomed S.A. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis
• Bacterial Vaginitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic	antibiotic plus probiotic
OTHER	placebo	antibiotic plus placebo

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2013-11-25
• Last updated: 2013-11-25