The online version of this article (doi:10.1186/s12905-015-0246-6) contains supplementary material, which is available to authorized users.
Authors AMC and MSS represent IBSS BIOMED S.A., the company which has sponsored the research and manufactures the product used in the trial.
PBH, AMC, MS were involved in the design of the study protocol; PBH wrote the manuscript and was microbiological expert; AT was responsible for data collection and edited the manuscript; MS contributed to the interpretation of findings; PA was responsible for statistical analysis; AJJ was study clinical expert and safety assessor, MSS was responsible for coordination of the study and was co-author of final report; AMC was the supervisor of the whole clinical project, GS was responsible for the study design. All authors approved the final version of the manuscript.
This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV).
Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5–6 (I, II, II bis – if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18–50-year-old women who were randomised.
BV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment.
This study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters.
NCT01993524; 20 November 2013.
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- Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial
Piotr B. Heczko
Artur J. Jakimiuk
- BioMed Central
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