Work

Exploratory pilot study of a spray-type probiotic delivery system for vaginal health in women at risk for bacterial vaginosis

Year: 2026

Type: article

Abstract: Background Bacterial vaginosis (BV) is a common gynecological condition affecting women of reproductive age, characterized by disruption of vaginal microbiota. Current probiotic interventions, including oral supplements and vaginal suppositories, face limitations in vaginal colonization and user compliance. This study evaluated the efficacy and safety of a novel spray-type probiotic powder (BalanceTalk Probiotic Feminine Hygiene Powder) containing multiple Lactobacillus strains for BV prevention and treatment. Methods This single-arm exploratory clinical study was conducted at Ewha Womans University Hospital from December 2023 to June 2025. Premenopausal women aged 19–55 years were enrolled and instructed to apply the spray-type probiotic powder (containing L. plantarum, L. rhamnosus, L. paracasei, and L. crispatus ) to underwear or panty liners in contact with the vulvovaginal area once daily for 4 weeks. Primary outcomes included vaginal symptom improvement and Nugent score changes. Secondary outcomes assessed vaginal microbiome composition using 16S rRNA gene sequencing. Statistical analyses included Wilcoxon signed-rank test, McNemar’s test, and mixed-effects logistic regression. Results Of 60 enrolled participants, 45 completed the study (75% completion rate). Overall improvement in vaginal symptoms approached statistical significance ( p = 0.051), particularly in high-risk group (Nugent score ≥ 4; p = 0.020). In the high-risk group (n = 8), mean Nugent scores decreased significantly from 6.13 to 4.63 ( p < 0.001), with 50% achieving score improvement. Lactobacillus abundance demonstrated a significant negative correlation with Nugent score (OR = 0.077, 95% CI: 0.009–0.634). Alpha diversity indices correlated significantly with Nugent score ( p < 0.05). Beta diversity and overall Lactobacillus abundance showed no significant changes. Three mild adverse events were reported with no serious safety concerns observed. Conclusions The spray-type probiotic was associated with improvement in vaginal symptoms, and reduced Nugent scores, particularly in high-risk women, with an excellent safety profile. The significant correlation between Lactobacillus abundance and vaginal health suggests a potential association between Lactobacillus abundance and vaginal health of this intervention. Larger randomized controlled trials are warranted to confirm these findings and establish clinical utility.

Source: Scientific Reports

DOI: 10.1038/s41598-026-74965-8