Skip to main content
Log in

Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case–control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript



Bacterial vaginosis (BV) is the most prevalent lower genital tract infection in reproductive-age women worldwide. BV is an ecological disorder of the vaginal microbiota characterized microbiologically by replacement of the lactobacilli, predominant vaginal microbiota. It is characterized by a high rate of relapse in sexual active women, and these patients show three or more relapses each year. A healthy vagina is characterized by hydrogen peroxide and acid-producing lactobacilli, which are crucial to maintain the physiological vaginal ecosystem and their depletion speeds up bacterial overgrowth with pH elevation, salidase and amine production, leading to the observed signs and symptoms of BV. The aim of this study is to evaluate the efficacy of long-term vaginal lactobacilli’s implementation in restoring and maintaining vaginal microflora and pH and to collect data about prophylactic approach based on probiotics supplementation with lactobacilli.


This is a prospective case–control study, performed between January 2013 and September 2014 at Department of Gynecological Obstetrics and Urologic Sciences of “Sapienza” University of Rome. 250 non-pregnant sexually active women with diagnoses of BV were collected. Patients selected were divided in Group A (125 patients assigned to standard treatment for BV—metronidazole 500 mg orally twice a day for 7 days) and Group B (125 women undergoing the same standard antibiotic regimen followed by vaginal tablets containing Lactobacillus rhamnosus BMX 54). Patients were evaluated after 2, 6, and 9 months (T0, T2, T6, and T9) in term of recurrences rates of BV, vaginal symptoms, re-establishment of healthy vaginal flora, vaginal pH, and treatment tolerability.


Vaginal flora was significantly replaced in Group B patients after 2 months comparing with Group A (p = 0.014). These data were confirmed at 6 and 9 months follow-up: patients that underwent prophylactic therapy with NORMOGIN® experienced significantly low rate of recurrences comparing with patients treated with antibiotics only (p < 0.001). During follow-up patients continuing supplementation had significant pH decrease respect to other patients (p < 0.001 at 9 months follow-up visit).


Probiotic supplementation with vaginal Lactobacillus rhamnosus BMX54 seems to be useful in hindering bacteria growth especially after antibiotic therapy; therefore this intervention may be considered a new prophylactic treatment for preventing recurrence of BV, in particular in high-risk patients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others


  1. CDC Centers for Disease Control and Prevention (2006) Pathogenesis of abnormal vaginal Xora. Am J Obstet Gynecol 182:872–878

    Google Scholar 

  2. Ventolini G (2015) Vaginal Lactobacillus: biofilm formation in vivo—clinical implications. Int J Womens Health 7:243–247

    Article  PubMed  PubMed Central  Google Scholar 

  3. Martin DH (2012) The microbiota of the vagina and its influence on women’s health and disease. Am J Med Sci 343:2–9

    Article  PubMed  PubMed Central  Google Scholar 

  4. Institute of Medicine (US) Forum on Microbial Threats (2012) The social biology of microbial communities: workshop summary. National Academies Press (US), Washington (DC)

  5. Eschenbach DA (1993) History and review of bacterial vaginosis. Am J Obstet Gynecol 169:441–445

    Article  PubMed  CAS  Google Scholar 

  6. Hill GB (1993) The microbiology of bacterial vaginosis. Am J Obstet Gynecol 169:450–454

    Article  PubMed  CAS  Google Scholar 

  7. Holst E (1987) Bacterial vaginosis microbiological and clinical findings. Eur J Clin Microbiol 6:536–541

    Article  PubMed  CAS  Google Scholar 

  8. Kumar Nikhil, Behera Beauty, Sagiri Sai S, Pal Kunal, Ray Sirsendu S, Roy Saroj (2011) Bacterial vaginosis: etiology and modalities of treatment—a brief note. J Pharm Bioallied Sci 3:496–503

    Article  PubMed  PubMed Central  Google Scholar 

  9. Antonio MA, Hawes SE, Hillier SL (1999) The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis 180:1950–1956

    Article  PubMed  CAS  Google Scholar 

  10. Donders GG (2007) Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol 21:355–373

    Article  PubMed  Google Scholar 

  11. Amsel R, Totten PA, Spiegel CA, Chen KC, Eschenbach D, Holmes KKb(1983). Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med 74:14–22

  12. Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J (1994) Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ 308:295–298

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  13. Ison CA, Hay PE (2002) Validation of a simplified grading of Gram stained vaginal smears for use in genitourinary medicine clinics. Sex Transm Infect 78:413–415

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  14. Nugent RP, Krohn MA, Hillier SL (1991) Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 29:297–301

    PubMed  CAS  PubMed Central  Google Scholar 

  15. Vicariotto F, Mogna L, Del Piano M (2014) Effectiveness of the two microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, formulated in slow-release vaginal tablets, in women affected by bacterial vaginosis: a pilot study. J Clin Gastroenterol 48:S106–S112

    Article  PubMed  Google Scholar 

  16. Parent D, Bossens M, Bayot D, Kirkpatrick C, Graf F (1996) Therapy of bacterial vaginosis using exogenously-applied Lactobacillus aciophili and a low dose of estriol: a placebo-controlled multicentric clinical trial. Arzneimitell Forschung 46:68–73

    CAS  Google Scholar 

  17. Hay PE (1998) Recurrent bacterial vaginosis. Dermatol Clin 16:769–773, xii–xiii

  18. Carey JC, KlebanoV MA, Hauth JC, Hillier SL, Thom EA, Ernest JM, Heine RP et al (2000) Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. N Engl J Med 342:534–540

    Article  PubMed  CAS  Google Scholar 

  19. Bradshaw CS, Morton AN, Hocking J et al (2006) High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 193:1478–1486

    Article  PubMed  Google Scholar 

  20. Mastromarino P, Vitali B, Mosca L (2013) Bacterial vaginosis: a review on clinical trials with probiotics. New Microbiol 36:229–238

    PubMed  Google Scholar 

  21. Homayouni A, Bastani P, Ziyadi S, Mohammad-Alizadeh-Charandabi S, Ghalibaf M, Mortazavian AM, Mehrabany EV (2014) Effects of probiotics on the recurrence of bacterial vaginosis: a review. J Low Genit Tract Dis 18:79–86

    Article  PubMed  Google Scholar 

  22. Marcone V, Calzolari E, Bertini M (2008) Effectiveness of vaginal administration of Lactobacillus rhamnosus following conventional metronidazole therapy: how to lower the rate of bacterial vaginosis recurrences. New Microbiol 31:429–433

    PubMed  CAS  Google Scholar 

  23. Cadieux P, Burton J, Gardiner G, Braunstein I, Bruce AW, Kang CY, Reid G (2002) Lactobacillus strains and vaginal ecology. JAMA 287:1940–1941

    Article  PubMed  Google Scholar 

  24. Anukam K, Osazuwa E, Ahonkhai I, NgwuM Osemene G, Bruce AW et al (2006) Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect 8:1450–1454

    Article  PubMed  CAS  Google Scholar 

  25. YaW Reifer C, Miller LE (2010) Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebocontrolled study. Am J Obstet Gynecol 203:120–125

    Google Scholar 

  26. Reid GK, Mills AP, Bruce AW (1994) Implantation of Lactobacilli Casei var-rhamnosus into the vagina. Lancet 344:1229

    Article  PubMed  CAS  Google Scholar 

  27. Reid G, Burton J (2002) Use of lactobacillus to prevent infection by pathogenic bacteria. Microbes Infect 4:319–324

    Article  PubMed  Google Scholar 

  28. Recine N, Musciola A, Moreira E. The benefits of topical vaginal therapy with Lactobacillus casei sub-rhamnosus in preventing bacterial vaginosis relapses. Communications and Posters for the X National IBAT Conference 2011, Naples, 26–28 Jan, 18(suppl 1)

  29. Rossi A, Rossi T, Bertini M (2010) The use of Lactobacillus rhamnosus in the therapy of bacterial vaginosis. Evaluation of clinical efficacy in a population of 40 women treated for 24 months. Arch Gynecol Obstet 281:1065–1069

    Article  PubMed  Google Scholar 

  30. Bertini M (2013) Is Lactobacillus Rhamnosus BMX 54 vaginal application a good strategy to counteract bacterial vaginosis recurrences? 18th World Congress on Controversies in Obstetrics, Gynecology and Infertility (COGI), 24–27 Oct, 2013, Vienna, Austria, Code 1766, pp 339–345

  31. Parma M, Stella Vanni V, Bertini M, Candiani M (2014) Probiotics in the prevention of recurrences of bacterial vaginosis. Altern Ther Health Med 20:52–57

    PubMed  Google Scholar 

  32. Mc Lean N, Rosenstein IJ (2000) Characterisation and selection of a Lactobacillus species to re- colonise the vagina of women with recurrent bacterial vaginosis. J Med Microbiol 49:543–552

    Article  CAS  Google Scholar 

  33. Gardiner GE, Heinemann C, Bruce AW, Beuerman D, Reid G (2002) Persistence of Lactobacillus fermentum RC-14 and Lactobacillus rhamnosus GR-1 but not L. Rhamnosus GG in the human vagina as demonstrated by randomly amplified polymorphic DNA. Clin Diagn Lab Immunol 9:92–96

    PubMed  CAS  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations


Corresponding author

Correspondence to Lavinia Domenici.

Ethics declarations

Conflict of interest

All authors have no financial relationship with the organization that sponsored the research and they have had full control of all primary data and that they agree to allow the Journal to review their data if requested.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Recine, N., Palma, E., Domenici, L. et al. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case–control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet 293, 101–107 (2016).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: