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

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28001
      • HM Gabinete Velázquez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women in peri- and/or postmenopause period (up to 5 years after last menstruation) Perimenopause is defined as if changes in the menstrual cycle (such as longer or shorter cycles, absence of any menstrual cycle, or abnormally heavy or prolonged bleeding) have occurred in the previous 12 months.
2. Age 45-60 years.
3. Cervantes quality of life scale score ≥ 38 at the screening visit.
4. Willing to sign the informed consent.
5. Willing to maintain dietary or lifestyle habits during the study.

Exclusion Criteria:

1. Regular use of probiotics other than the probiotics under study (in the form of food supplements or in foods such as "bifidus" type yogurt) in the month prior to the baseline visit.
2. Use of oral or injectable antibiotics in the last month before the start of the study.
3. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
4. Diagnosis of active oncological disease.
5. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
6. Type 1 diabetes.
7. Untreated or unstable thyroid disease.
8. Diagnosis of severe renal, cardiac or hepatic disease.
9. Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
10. Diagnosis of celiac disease
11. Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
12. Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; Probiotic formulation comprising Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021	Dietary supplement: Probiotic; Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 in concentration of 1E09 CFU/capsule
Placebo Comparator: Placebo; Placebo comparator arm with identical pharmaceutical form and aspect	Other: Placebo; Placebo comparator containing maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by the Cervantes Scale	Changes in the Cervantes Scale T standardized score obtained using the mean and standard deviation of the population of young women (20-44 years). Cervantes scale is a validated questionnaire developed for Spanish population comprising 31 items which score from 0 to 5	Baseline, 30 days, 60 days, 90 days
Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale	Changes in total MRS score throughout the study. MRS is a 11-item validated questionnaire, each item scoring from 0 to 4. Scores ranging from 0-4, 5-8, 9-15, and 16+ are used to rate the perceived symptoms as none/minimal, mild, moderate, and severe, respectively	Baseline, 30 days, 60 days, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by the Cervantes Scale subscores	Changes in the subscores of the different domains of the Cervantes® Scale: Menopause and Health, Psychological, Sexuality and Relationship.	Baseline, 30 days, 60 days, 90 days
Menopause-related symptoms evaluated by MRS scale sub-scores	Changes in the subscores of the different domains of the MRS Scale: Vegetative, Urogenital and Mental.	Baseline, 30 days, 60 days, 90 days
Utian Quality of Life scale	Changes in quality of life total score and sub-scores using the Utian Quality of Life (UQOL) scale. This scale measures quality of life in perimenopause period and comprises 23 items evaluating the following domains: occupational, health, emotional and sexual QOL	Baseline, 90 days
Gastrointestinal symptoms	Assessment of digestive tolerance based on gastrointestinal symptoms documented on the Gastrointestinal Symptom Rating Scale (GSRS).	Baseline, 90 days
Symptoms vaginal infections	Number of days with any of the following vaginal symptoms: itching, irritation or abnormal vaginal discharge.	Baseline, 30 days, 60 days, 90 days

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Investigators: Principal Investigator: Silvia González Rodríguez, HM hospitales

Publications and helpful links

General Publications

• Honda S, Tominaga Y, Espadaler-Mazo J, Huedo P, Aguilo M, Perez M, Ueda T, Sawashita J. Supplementation with a Probiotic Formula Having beta-Glucuronidase Activity Modulates Serum Estrogen Levels in Healthy Peri- and Postmenopausal Women. J Med Food. 2024 Aug;27(8):720-727. doi: 10.1089/jmf.2023.k.0320. Epub 2024 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): December 14, 2024
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Menopause; Probiotic
• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: AB-GynMeno-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No