NCT06604234

Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of the Combination of Three Probiotic Strains on Quality of Life and Symptoms in Peri- and Postmenopausal Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In this randomized, placebo-controlled, double-blind study, we aim to investigate if the active product consisting of a probiotic blend can improve the quality of life and alleviate symptoms in peri- and postmenopausal women, using validated questionnaires.

Detailed description

Fifty to 80% of women around menopause or already in postmenopause complain about symptoms such as hot flashes, night sweats, sleep disturbances, tiredness, and depression, which negatively impact their quality of life. The aim of this study was to evaluate the effects of a multiprobiotic strain on the quality of life and menopause-associated symptoms. The study is a de-centralized, prospective, randomized, placebo-controlled, double-blind study in which peri- and postmenopausal women will be recruited and randomly assigned (ratio 2:1) to receive either a probiotic blend or placebo formulation in capsules form for 12 weeks. We aim to recruit up to 300 women. On a monthly basis, quality of life will be evaluated by using the validated Spanish Quality of Life Cervantes questionnaire. In addition, other questionnaires will be administered to monitor menopause-related symptoms (Menopause Rating Scale, MRS) and health-related quality of life (Utian Quality of Life). This will be documented through a specifically designed, web-based platform. Main study variable is change in the global score in MRS scores and Cervantes quality of life scores throughout study period.

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 in concentration of 1E09 CFU/capsule
OTHER	Placebo	Placebo comparator containing maltodextrin

Timeline

• Start date: 2024-09-16
• Primary completion: 2024-12-14
• Completion: 2025-01-17
• First posted: 2024-09-19
• Last updated: 2025-12-04

Locations

1 site across 1 country: Spain