Women’s health: AB-BIOTICS, KANEKA PROBIOTICS reveal results of new clinical study

New research reveals that probiotic strain L. gasseri KABP® 064 (CECT 30648) from AB-BIOTICS and KANEKA PROBIOTICS shows potential to colonize the vaginal tract and support a balanced vaginal environment, following oral administration. Examining healthy women aged 18-45 years over 18 days, the randomized, double-blind and placebo-controlled clinical trial reported that L. gasseri KABP® 064 was detected in the vaginal tract of 55.9% of participants receiving the probiotic strain^.[i] Together with in vitro investigations showing broad-spectrum inhibitory activity against a range of urogenital microorganisms, including certain bacteria and yeast[i], these findings suggest L. gasseri KABP® 064 could be effective in promoting vaginal health.

“A healthy vaginal ecosystem is crucial for supporting women’s urogenital health^,[i],[ii] which can significantly impact women’s day-to-day lives,” comments Marta Pérez, R&D Manager at AB-BIOTICS and lead author of the study. “The administration of probiotics via vaginal tablets or creams has demonstrated efficacy in reducing infection recurrence,^[iii],[iv] however, oral probiotics for vaginal health remains relatively understudied, despite its many advantages, including patient experience and compliance. Probiotic strains for oral consumption must withstand the harsh and diverse environments of the oral-gut-vaginal route. This study aimed to identify strains of vaginal lactobacilli that can resist gastrointestinal conditions and colonize the vaginal tract to support a balanced microbiota.”

L. gasseri strain

Healthy vaginal microbiota is dominated by beneficial Lactobacillus species, particularly L. gasseri and L. crispatus, which preserve a balanced, acidic pH, inhibiting the growth of pathogens. Combating vaginal dysbiosis, characterized by a reduction in lactobacilli and an increase in microbial diversity, is emerging as a key strategy to support urogenital and reproductive health^.[v],[vi]  

In the first phase of the new study, a selection of 45 vaginal lactobacilli isolates from AB-BIOTICS-KANEKA collection^,[vii] were screened in vitro in order to rationally select strains showing potential to promote vaginal health. In the in vitro screening, L. gasseri KABP® 064 and a L. crispatus strain showed tolerance to simulated gastrointestinal and vaginal conditions (including conditions replicating vaginal dysbiosis), as well as strong capacity to adhere to vaginal epithelial cells.^[i] L. gasseri KABP® 064 and L crispatus strains also displayed broad-spectrum ability to impact various microorganisms found in the vaginal environment, including  bacterial and fungal species associated with certain urogenital conditions and pregnancy outcomes.[i]

In the subsequent randomized, double-blind, and placebo-controlled clinical trial, 46 healthy premenopausal women aged 18-45 years took one capsule daily of either L. gasseri KABP® 064 alone, L. gasseri KABP® 064 and L. crispatus CECT 30647 or placebo over 18 days. Vaginal swabs were taken every 3 days to be analyzed by qPCR (quantitative polymerase chain reaction) for the presence of the two test strains. L. crispatus CECT 30647 was not detected at any timepoint, so the data from the two active groups were combined for further analyses as the probiotic group.

Over the course of the trial, L. gasseri KABP® 064 was detected in 19 out of 34 participants (55.9%) in the probiotic group, and in one out of 12 (8.3 %) in the placebo group, this difference being statistically significant (p=0.008). In the probiotic group, L. gasseri KABP® 064 was detected as early as day 3 in four of the volunteers (11.8%) and peaked at day 6 with positive samples from 8 participants (23.5%).^[i]

Secondary findings of the trial revealed a significant reduction in non-lactobacilli genera and positive shifts in ‘vaginotypes’ (the make-up of a vaginal microbiome) in the probiotic group. Although all participants were healthy and asymptomatic, several presented with vaginotypes that are considered unstable and potentially predisposed to the development of microbial imbalance. By day 15 of the trial, while vaginotype distribution remained stable in the placebo group, the probiotic group showed a positive transition towards more healthy, Lactobacilli-dominated vaginotypes. This suggests that oral supplementation with L. gasseri KABP® 064 could help to restore and maintain a balanced vaginal microbial environment.

“The findings of this research position L. gasseri KABP® 064 probiotic strain, marketed as Gyntima® Balance outside of the U.S., as a promising probiotic for promoting vaginal health,” Pérez summarizes. “Together with the inhibitory activity demonstrated in vitro, the potential of L. gasseri KABP® 064 to colonize and restore the vaginal environment suggests it could effectively support women’s intimate health by reducing the impacts of vaginal microbiome imbalance. We’re excited to continue our research into the potential benefits that Gyntima® Balance can offer women worldwide.”