Recruiting

Probiotic Blend for Menopausal Symptoms and Quality of Life Improvement

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Gyntima Menopause

+ Placebo

Dietary SupplementOther
Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Hot Flashes

From 42 to 60 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorCommunity Pharmacology Services Ltd
Study ContactKristen Laing, MBChBMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 10, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore whether a specific combination of probiotics can help alleviate symptoms experienced by women during menopause, a time when hormone levels naturally decrease. The study focuses on peri- and post-menopausal women, aiming to see if these probiotics can enhance the presence of active oestrogens in the blood, which might ease menopause-related symptoms. This research is important because many women seek natural ways to manage menopause symptoms, and finding effective probiotic solutions could offer a new, non-hormonal option for improving their quality of life. Participants in the study will receive either the probiotic blend or a placebo, ensuring that the results can be accurately measured without bias. The probiotics are taken orally, as part of the daily routine. The study does not specify exact measurements or outcomes it will monitor, but it usually involves checking changes in symptoms and overall quality of life. By observing any differences between the group taking the probiotics and the placebo group, researchers aim to determine the effectiveness and safety of this probiotic treatment for menopause symptoms.

Official TitleRandomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women
NCT06446869
Principal SponsorCommunity Pharmacology Services Ltd
Study ContactKristen Laing, MBChBMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 42 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsPathological Conditions, Signs and SymptomsHot Flashes

Criteria

8 inclusion criteria required to participate
Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35 or more per week recorded daily for 14 consecutive days)

BMI between 18.5 and 34.9 kg/m2

Menopause rating score II (MRS-II) total score of 9 or more at baseline visit

Willing to sign Informed Consent Form

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21 exclusion criteria prevent from participating
History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or cancers associated with sex hormones

Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months prior to the start of the study

Intake of herbal or food supplements with known effects on menopause symptoms within 1 month prior to the start of the study. Examples of prohibited substances are black cohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop [Humulus lupulus L.], soy isoflavones, red clover) within 1 month prior to the start of the study

Use of any food supplement containing probiotics or postbiotics or regular consumption (>3 days/week) of foods containing probiotics (including yogurt with added probiotics or bifidus effect) within 1 month prior to the start of the study

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Study treatment

Group II

Placebo
Placebo comparator arm

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

FutureMeds Glasgow

Glasgow, United KingdomOpen FutureMeds Glasgow in Google Maps
Recruiting
One Study Center