Efficacy of a probiotic formula in the management of menopausal symptoms and quality of life: a randomized controlled trial

Abstract

OBJECTIVES: Estrogen decline during menopause transition is associated with physical and psychological symptoms that impair overall well-being. In a previous randomized trial, a probiotic formula comprising Levilactobacillus brevis KABP052, Lactiplantibacillus plantarum KABP051, and Pediococcus acidilactici KABP021 was found to be associated with a slower decline in estrogen levels. Therefore, we hypothesized that the intake of 1×109 colony-forming units/day of this formula could improve menopausal symptoms and quality of life. METHODS: We conducted a decentralized, randomized, double-blind, placebo-controlled trial using a real-world approach. Women between 45 and 60 years old who were in perimenopause or postmenopause and had Cervantes Quality of Life score ≥ 38 were enrolled and allocated 2:1 to the probiotic (n=160) or placebo group (n=85) for a 3-month period. Menopausal symptoms and quality of life were evaluated by using the Menopause Rating Scale II, Cervantes and Utian Quality of Life questionnaires. RESULTS: In the full analysis set, Menopause Rating Scale II total score decreased significantly in the probiotic group compared to placebo across the study (global mean difference between groups: -1.00 [0.47], P=0.033), with an improvement in the somato-vegetative domain (-0.54 [0.20], P=0.007). Per-protocol analysis also revealed differences in the psychological domain between groups, favoring the probiotic (-0.51 [0.25], P=0.040). Cervantes scale showed no significant differences between groups, but the change in Utian Quality of Life score was significantly higher in the probiotic group (2.21 [1.07], P=0.040). CONCLUSION: In this real-world study, the probiotic formula was associated with improvements in menopause-associated symptoms and quality of life, whereas the global Cervantes score appeared to be similar between groups. Future investigations are required to confirm this clinical effect and the underlying mechanisms of action. ClinicalTrials.gov identifier: NCT06604234.