Gut health boost? probiotic blend tested for menopause symptom relief

NCT ID NCT06604234

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a daily probiotic capsule containing three bacterial strains could improve quality of life and reduce menopause symptoms in 245 women aged 45-60 who were in perimenopause or early postmenopause. Participants took either the probiotic or a placebo for several weeks, and their symptoms and well-being were tracked using standard questionnaires. The goal was to see if this simple supplement could offer relief without hormones.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a blend of three probiotic strains (Levilactobacillus brevis, Lactiplantibacillus plantarum, and Pediococcus acidilactici)
What this could lead to
If it works, this could offer a natural, non-hormonal option to help manage menopause symptoms and improve daily well-being.
What could go wrong
This is a completed study, but probiotics are not a proven treatment for menopause. The effect may be small or no better than a placebo, and results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

245 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • HM Gabinete Velázquez

    Madrid, Madrid, 28001, Spain

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