Randomized Trial Reports Symptom and Quality-of-Life Improvements With Multi-Strain Probiotic in Menopausal Women

A randomized controlled trial published in Menopause has evaluated a three-strain probiotic formula for its effect on menopausal symptoms and quality of life.¹ The formula, developed by AB-Biotics (a Kaneka Corporation company), is marketed as KABP Menopause in the United States and Gyntima Menopause in Europe.²

Over a 3-month period, the probiotic group showed significantly greater improvement than placebo in total menopausal symptom scores and in a separate quality-of-life measure, while a third quality-of-life scale showed no significant overall difference between groups.

“More than one billion women worldwide are currently experiencing or have gone through the menopausal transition, which profoundly impacts multiple aspects of health and quality of life,” stated María Rodríguez-Palmero, medical director at AB-BIOTICS, and lead author on the study. “While scientific investment and innovation in this area have expanded over recent years, consumer research suggests that the vast majority of women feel poorly served by the solutions currently available to them.”

How Was the Study Designed?

The trial combined Levilactobacillus brevis KABP052, Lactiplantibacillus plantarum KABP051, and Pediococcus acidilactici KABP021, dosed at 1×10⁹ CFU per day. It was conducted as a decentralized, double-blind, placebo-controlled study with a 2:1 allocation ratio, using a real-world approach in which participants maintained their usual diet and lifestyle. Of 374 women screened, 245 aged 45 to 60 who were perimenopausal or postmenopausal and met a minimum Cervantes quality-of-life score were randomized: 160 to the probiotic and 85 to placebo, over a 3-month intervention. Co-primary endpoints were the Menopause Rating Scale II (MRS II) and the Cervantes Quality of Life scale, while secondary endpoints included the Utian Quality of Life (UQOL) scale and gastrointestinal tolerance.

What Did the Results Show?

Total MRS II score decreased significantly more in the probiotic group than placebo across the study period, with significant improvement in the somato-vegetative domain and, in the per-protocol population, the psychological domain. Heart discomfort, sleep problems, and depressive mood improved significantly more with the probiotic; hot flushes did not differ significantly between groups.

The Cervantes scale showed no significant overall difference between groups, though its "health" subdomain reached significance. UQOL scores improved significantly more in the probiotic group. Adverse-event reporting rates did not differ significantly between groups (66.4% probiotic vs. 75.0% placebo), and no serious adverse events were reported.

What Are the Limitations and Open Questions?

The authors note that the placebo group also showed a substantial reduction in MRS II score, narrowing the net between-group effect, a pattern they attribute to the subjective nature of the outcomes measured. The trial did not include blood or gut microbiota sampling, so the proposed estrogen-related mechanism was not directly tested, and diet, adherence, and concomitant supplement use were not controlled or were self-reported. The population was also predominantly Caucasian, limiting generalizability.

The study was funded by AB-Biotics, and several authors are employees of AB-Biotics or Trialance, the contract research organization involved in the trial. It is registered at ClinicalTrials.gov (NCT06604234).

What Are the Marketing Opportunities According to the Company?

“Together, these findings demonstrate how KABP® Menopause / Gyntima Menopause can support women navigating the menopausal transition by targeting the root cause of symptoms,” stated Jordi Riera, chief business officer at Kaneka Probiotics. “As demand for natural, hormone-free menopause support continues to accelerate, the need for clinically substantiated ingredients has never been greater. No other probiotic ingredient has this depth of clinical evidence for estrogen modulation, which gives supplement formulators a differentiated, science-backed foundation meeting that demand.”

The company notes that the current findings build on earlier research showing the same three-strain formula helped sustain estrogen levels in peri- and postmenopausal women through β-glucuronidase enzyme activity, with the lead strain, L. brevis KABP 052, selected from more than 80 candidates for this activity.

Additionally, the formula is described as the first commercially available probiotic ingredient with clinical evidence spanning both estrogen modulation and menopausal symptom improvement.

References

1. Rodríguez-Palmero M, Prat C, Molina X, et al. Efficacy of a probiotic formula in the management of menopausal symptoms and quality of life: a randomized controlled trial. Menopause. Published online. August 4, 2026. doi:10.1097/GME.0000000000002871
2. AB-BIOTICS, Kaneka Probiotics. AB-BIOTICS and Kaneka Probiotics' probiotic blend becomes first shown in clinical trials to modulate estrogen and improve symptoms in peri- and postmenopausal women. August 11, 2026. Accessed August 14, 2026.