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

What this trial studies

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 in scope

• Menopause

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
• Placebo (Other) — Placebo comparator containing maltodextrin

Who can join

Women only · Ages 45 Years to 60 Years

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-09-16
• Primary completion: 2024-12-14
• Last update posted: 2025-12-04
• First posted: 2024-09-19

Sponsor & contact

Lead sponsor: AB Biotics, SA (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Quality of life measured by the Cervantes Scale (Baseline, 30 days, 60 days, 90 days)
  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
• Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale (Baseline, 30 days, 60 days, 90 days)
  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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.