Writing in the journal Nutrients, the researchers evaluated the efficacy of the company's Femme supplement—a blend of Lactiplantibacillus plantarum PBS067, Bifidobacterium animalis subsp. lactis BL050 and Lacticaseibacillus rhamnosus LRH020— against vaginal dysbiosis and inflammation from vaginal infection in 50 healthy postmenopausal women.
“Within just 28 days of product intake, we observed a notable increase in the abundance of lactobacilli and bifidobacteria species, accompanied by a significant reduction in Streptococcus and other pathogenic genera,” Patrizia Malfa, R&D manager at SynBalance, told NutraIngredients.
Restoring vaginal microbiota
Menopause results in a significant decline in estrogen and progesterone levels, leading to increased incidence of irritating genital symptoms, as well as thinning of the vaginal mucosa and the reduction of vascularisation, with a consequent loss of elasticity and hydration.
Estrogen is crucial for glycogen production which provides nutrients for lactobacilli growth and contributes to vaginal health.
Lactic acid bacteria, especially lactobacilli, help maintain vaginal homeostasis through various mechanisms, and the reduction of lactobacilli and an increase in pathogenic species lead to a rise in the vaginal pH.
Previous research conducted by SynBalance in women between the ages of 18 and 45 years demonstrated the effectiveness of Femme in the prevention of BV recurrences, restoration of a balanced microbiota, alleviation of inflammation and promotion of the growth of beneficial lactobacilli (especially L. crispatus), Malfa explained.
The probiotics have been shown to support the formation of a probiotic monolayer and an acidic microenvironment, which prevents pathogen adhesion, but also inhibits pathogen cell growth through co-aggregation with G. vaginalis, E. coli and C. albicans.
However, SynBalance realized the significance of addressing a crucial and overlooked demographic, Malfa explained.
“Throughout these demographics, an unbalanced vaginal microbiota and urogenital infections emerged as shared concerns,” she noted. “We have shifted our attention to menopausal women, recognizing the differences and meeting point from one life stage to another.”
Probiotic supplementation
In this prospective, observational clinical trial, 50 female participants between the ages of 45 and 65 years (in menopause for at least 18 months) consumed one capsule containing 3 × 109 CFU/g (1 × 109 CFU/g of each probiotic strain), vitamin B3 and maltodextrin daily for four consecutive weeks.
Health status was assessed at baseline (T0), after four weeks of oral probiotic supplementation (T1) and after a four-week follow-up (T2), with vaginal swabs collected at T0 and T1 to evaluate microbiota fluctuation and record inflammatory patterns.
Results showed significant improvements across various parameters: a 50% enhancement in the Vaginal Health Index (VHI) score and substantial reductions in inflammatory cytokine levels, namely IL-6 (-87.8%), IL-1β (-57.6%) and TNF-α (-40.8%).
Moreover, the probiotic intervention facilitated the restoration of vaginal microbiota, evidenced by an increase in lactobacilli abundance.
While the researchers concluded that the Femme probiotic combination was effective in postmenopausal women, they did note that future studies could include a placebo arm and a longer test period for a more comprehensive understanding of efficacy.
Malfa explained that by expanding the research in postmenopausal women, SynBalance aims to broaden and disseminate knowledge in this area, breaking down taboos associated with this life stage.
Journal: Nutrients
doi: 10.3390/nu16030402
"Efficacy of Lactiplantibacillus plantarum PBS067, Bifidobacterium animalis subsp. lactis BL050, and Lacticaseibacillus rhamnosus LRH020 in the Amelioration of Vaginal Microbiota in Post-Menopausal Women: A Prospective Observational Clinical Trial"
Authors: Franco Vicariotto et al.