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Randomized Controlled Trial
. 2024 Dec 22;16(24):4406.
doi: 10.3390/nu16244406.

Efficacy of Oral Probiotic Supplementation in Preventing Vulvovaginal Infections During Pregnancy: A Randomized and Placebo-Controlled Clinical Trial

Enav Yefet  1   2   3 , Abeer Suleiman  4   5 , Raul Colodner  6 , Shlomo Battino  2   3 , Malak Wattad  5 , Olga Kuzmin  4 , Zohar Nachum  5   7
Affiliations
Randomized Controlled Trial

Efficacy of Oral Probiotic Supplementation in Preventing Vulvovaginal Infections During Pregnancy: A Randomized and Placebo-Controlled Clinical Trial

Enav Yefet et al. Nutrients. .

Abstract

Background/objective: This study aimed to investigate the efficacy of oral probiotic supplementation in preventing vulvovaginal infections (VVIs) in pregnant women, specifically focusing on abnormal vaginal flora (AVF), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC).

Methods: A multicenter-prospective-randomized, double-blind, placebo-controlled trial was conducted during 2016-2019. Women with normal vaginal flora (Nugent score < 4 and no candida) were divided into a research group, receiving 2 capsules/day of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Streptococcus thermophilus, or a control group, receiving a placebo until delivery. Once a month and following complaints, a vaginal smear was taken to assess vaginal flora. Vaginal colonization with the specific lactobacilli from the probiotic capsules was detected using the matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. The primary outcome was the rate of women who developed VVI.

Results: Forty-nine and fifty-one women were analyzed in the probiotic and placebo cohorts, respectively. There was no difference in the rate of VVI between probiotic and placebo groups (14 (29%) versus 14 (27%), respectively; p = 0.80). No woman had vaginal colonization with lactobacilli from the probiotic capsule.

Conclusions: The tested oral probiotic product did not reduce the rate of VVI in pregnant women with normal vaginal flora.

Keywords: abnormal vaginal flora; bacterial vaginosis; pregnancy; prevention; probiotics; vulvovaginal candidiasis; vulvovaginal infections.

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Conflict of interest statement

All the authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Patients’ flow chart.
Figure 2
Figure 2
The rate of vulvovaginal infections (VVI) throughout the study in the probiotic (N = 49) and placebo (N = 51) groups. The study participants were invited for vaginal swab once in every month until delivery. Repeated vaginal swabs for verifying VVI eradication are not presented. p > 0.05 for all the time points.
Figure 3
Figure 3
Kaplan–Meier survival curve representing the time from enrollment to the first vulvovaginal infection.
Figure 4
Figure 4
Percentage of vaginal lactobacilli (L.) strains from the study participants according to the study groups (46 and 45 women in the probiotic and placebo groups, respectively). Data from baseline (lower panel) and the last vaginal culture (upper panel) are presented. Regarding culture from the last visit, in 11 and 5 women, 2 L. strains were identified in culture in the probiotic and placebo groups, respectively. Two women in each group had 3 L. strains. The strains are listed in all the appropriate places. Comparison of the bacterial composition between both groups was not statistically significant (p = 0.06).
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