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

NCT06604234 | Completed

• 1 other identifier: AB-GynMeno-24
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Keywords

Probiotic; Menopause; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Quality of life measured by the Cervantes Scale subscores

  Baseline, 30 days, 60 days, 90 days

• Menopause-related symptoms evaluated by MRS scale sub-scores

  Baseline, 30 days, 60 days, 90 days

• Utian Quality of Life scale

  Baseline, 90 days

• Gastrointestinal symptoms

  Baseline, 90 days

• Symptoms vaginal infections

  Baseline, 30 days, 60 days, 90 days

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic formulation comprising Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo comparator arm with identical pharmaceutical form and aspect

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 in concentration of 1E09 CFU/capsule

Probiotic

Placebo OTHER

Placebo comparator containing maltodextrin

Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age 45-60 years.
• Cervantes quality of life scale score ≥ 38 at the screening visit.
• Willing to sign the informed consent.
• Willing to maintain dietary or lifestyle habits during the study.

You may not qualify if:

• 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.
• Use of oral or injectable antibiotics in the last month before the start of the study.
• Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
• Diagnosis of active oncological disease.
• Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
• Type 1 diabetes.
• Untreated or unstable thyroid disease.
• Diagnosis of severe renal, cardiac or hepatic disease.
• Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
• Diagnosis of celiac disease
• Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
• Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

HM Gabinete Velázquez

Madrid, Madrid, 28001, Spain

Location

Related Publications (1)

• 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.

  PMID: 38742994 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Silvia González Rodríguez

  HM hospitales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled study

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: December 14, 2024
• Study Completion: January 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)