An oral probiotic formula for the secondary prevention of vulvovaginal infections in pregnant women neither colonized in the vagina nor reduced the rate of repeated vulvovaginal infection, according to a study in the American Journal of Gynecology & Obstetrics.
“During pregnancy, abnormal vaginal flora (AVF), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC) are associated with serious complications and discomfort,” wrote the authors. “We aimed to elucidate the effectiveness of oral probiotics in secondary prevention of BV/AVF and VVC in pregnant women.”
The multicenter, prospective randomized, double-blind, placebo-controlled trial was conducted at 3 medical centers between 2016 and 2021.
Following normal vaginal flora in repeated vaginal smears, women were divided into 2 groups: a research group that received 2 capsules a day of an oral probiotic formula containing bifidobacteriumbifidum, bifidobacteriumlactis, lactobacillus (L.), acidophilus, L. paracasei, L. rhamnosus and Streptococcus thermophilus ( >6X109/capsule); and a control group which received a placebo (2 capsules/day) until delivery.
The mean maternal age was 30.4 years in the probiotic group and 30.5 years in the placebo group.
Among vaginal symptoms, pruritus was reported by 65% of patients in the probiotic group and 50% in the placebo group, followed by a burning sensation in 26% and 33% of patients, respectively, dryness in 4% and 13%, respectively, and erythema in 4% and 21%, respectively.
No patient in either group had regular antibiotic use.
At least once a month or following complaints, a vaginal smear was taken to assess vaginal flora. If positive, BV/AVF or VVC were treated with antibiotics or antimycotic agent, respectively.
Eradication was evaluated by a repeated vaginal smear, whereas vaginal colonization with the specific lactobacilli from the probiotic capsules was detected via matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI TOF-MS).
The primary outcome was the percentage of women who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery.
A total of 23 women were analyzed in the probiotic cohort and 24 women in the placebo group.
There was no difference in the rate of any vulvovaginal infection between the probiotic and placebo cohorts: 48% (n = 11) and 67% (n = 16), respectively (P = 0.19).
For candida, the rates were 39% and 46%, respectively, and for BV, 43% and 46%, respectively.
The study also found no woman detected with vaginal colonization of the lactobacilli from the probiotic capsule.
Other findings were that the gestational week at first vaginal infection was 31.6 weeks in the probiotic group and 29.6% weeks in the placebo group, while the delivery week was 38.6 weeks vs. 38.3 weeks, respectively.
In addition, the percentage of small for gestational age (SGA) in the probiotic group was 4% compared to 13% in the placebo group.
Neonatal intensive care unit admission was 4% and 1%, respectively.
Preterm premature rupture of membrane was 4% for both groups, while chorioamnionitis was 0% in both groups.
Intrapartum fever was 4% among probiotics patients and 0% among placebo patients.
Endometriosis was 0% in both groups, as was neonatal sepsis and neonatal respiratory distress syndrome (RDS).
Intraventricular hemorrhage (IVH) was also 0% in the probiotics group, but 4% in the placebo group.