title: Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Nadia
authors.initials: N
authors.lastname: Recine
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Palma
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy. lavinia.domenici@uniroma1.it.
authors.forename: Lavinia
authors.initials: L
authors.lastname: Domenici
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Margherita
authors.initials: M
authors.lastname: Giorgini
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Ludovica
authors.initials: L
authors.lastname: Imperiale
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Carolina
authors.initials: C
authors.lastname: Sassu
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Musella
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Marchetti
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Ludovico
authors.initials: L
authors.lastname: Muzii
authors.affiliation: Department of Gynecological Obstetrics and Urologic Sciences, University Sapienza of Rome, Viale del Policlinico 1555, 00161, Rome, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Benedetti Panici
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D052201:Lacticaseibacillus rhamnosus; D008795:Metronidazole / Q000627:therapeutic use*; D064307:Microbiota; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology*; D016585:Vaginosis, Bacterial / Q000382:microbiology / Q000628:therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000890:Anti-Infective Agents; D008795:Metronidazole
keywords: Bacterial vaginosis; Lactobacillus rhamnosus BMX54; Probiotics; Vaginal flora