MenopauseGynMenoNCT06604234
Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women
A study testing Probiotic in people with Menopause, run by AB Biotics, SA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2024to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 in concentration of 1E09 CFU/capsule
PlaceboOther
Placebo comparator containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic formulation comprising Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo comparator arm with identical pharmaceutical form and aspect Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 30 days, 60 days, 90 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: Baseline, 90 days
Gastrointestinal symptoms
Assessment of digestive tolerance based on gastrointestinal symptoms documented on the Gastrointestinal Symptom Rating Scale (GSRS).
Measured: Baseline, 90 days
Symptoms vaginal infections
Number of days with any of the following vaginal symptoms: itching, irritation or abnormal vaginal discharge.
Measured: Baseline, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion14 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia González Rodríguez, Principal investigator, HM hospitales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604234
- Sponsor's protocol ID
- AB-GynMeno-24
- Acronym
- GynMeno
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38742994Rodriguez-Palmero M, Prat C, Molina X, Miras F, Huedo P, Perez M, Espadaler-Mazo J, Palacios S, Gonzalez SP. Efficacy of a probiotic formula in the management of menopausal symptoms and quality of life: a randomized controlled trial. Menopause. 2026 Aug 4. doi: 10.1097/GME.0000000000002871. Online ahead of print.
PubMed 42549656
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06604234
- Acronym / sponsor ID
- GynMeno / AB-GynMeno-24
- Conditions
- Menopause
- Keywords
- Probiotic, Menopause, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic formulation comprising Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo comparator arm with identical pharmaceutical form and aspect |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticCombination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 in concentration of 1E09 CFU/capsule | Dietary supplement | Probiotic |
| PlaceboPlacebo comparator containing maltodextrin | Other | Placebo |
Primary outcome
Quality of life measured by the Cervantes Scale
Time frame: 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
Time frame: 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
5 secondary outcomes
Quality of life measured by the Cervantes Scale subscores
Time frame: Baseline, 30 days, 60 days, 90 days
Menopause-related symptoms evaluated by MRS scale sub-scores
Time frame: Baseline, 30 days, 60 days, 90 days
Utian Quality of Life scale
Time frame: Baseline, 90 days
Gastrointestinal symptoms
Time frame: Baseline, 90 days
Symptoms vaginal infections
Time frame: Baseline, 30 days, 60 days, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 38742994Honda 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.
- Derived from this study: PubMed 42549656Rodriguez-Palmero M, Prat C, Molina X, Miras F, Huedo P, Perez M, Espadaler-Mazo J, Palacios S, Gonzalez SP. Efficacy of a probiotic formula in the management of menopausal symptoms and quality of life: a randomized controlled trial. Menopause. 2026 Aug 4. doi: 10.1097/GME.0000000000002871. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia González Rodríguez principal investigator
HM hospitales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Menopause, run by AB Biotics, SA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured by the Cervantes Scale (time frame: Baseline, 30 days, 60 days, 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604234, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.