Randomized, double-blind, placebo-controlled study of oral lactobacilli to improve the vaginal flora of postmenopausal women

Eur J Obstet Gynecol Reprod Biol. 2008 Nov;141(1):54-7. doi: 10.1016/j.ejogrb.2008.06.003. Epub 2008 Aug 12.

Abstract

Objective: The purpose of this randomized, double-blind, placebo-controlled study was to evaluate the influence of the orally administered probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 on the quality of the vaginal flora in postmenopausal women.

Study design: Postmenopausal women with Nugent scores between 4 and 6 in initial vaginal swab, were randomized into two groups. Women in the intervention group received probiotic capsules containing 2.5x10(9)CFU (colony forming units) each of lyophilized L. rhamnosus GR-1 and L. reuteri RC-14 and women in the control group received an oral placebo once daily, in both groups for 14 days. Final vaginal swabs were taken 1 day after the last administration of the medication. The primary efficacy variable was a change in the Nugent score between baseline and the end of the study of at least two grades in each individual patient.

Results: Seventy two women were recruited in the study, 35 assigned to the intervention group and 37 to the control group. Twenty-one of the 35 subjects (60%) in the intervention group and 6 of the 37 subjects (16%) in the control group showed a reduction in the Nugent score by at least two grades. The difference in the number of patients with improvement was highly significant (p=0.0001). The median difference in Nugent scores between baseline and the end of the study was 3 in the intervention group and 0 in the control group (p=0.0001).

Conclusion: Our results provide evidence for an alternative modality to restore the normal vaginal flora using specific probiotic strains administered orally.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Lactobacillus reuteri*
  • Lactobacillus rhamnosus*
  • Middle Aged
  • Postmenopause
  • Probiotics / administration & dosage*
  • Vagina / microbiology
  • Vaginosis, Bacterial / therapy*