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Gut health may boost bone density: probiotic study shows promise

NCT ID NCT06375668

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking daily probiotics (Lactobacillus plantarum and Lactobacillus paracasei) for 12 months could improve bone density in postmenopausal women with low bone mass. 170 women participated, taking either the probiotic or a placebo. The goal was to see if these friendly bacteria could help prevent osteoporosis and fractures.

What this could mean

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

Active substance
Lactobacillus plantarum and Lactobacillus paracasei probiotics
What this could lead to
If it works, this could offer a simple, natural way to help maintain bone density and reduce fracture risk in postmenopausal women.
What could go wrong
This is a completed study, but results are not yet widely confirmed. Probiotics may not significantly improve bone density, and individual results can vary.

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

170 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2024

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Postmenopausal women (between 2 and 5 years after their last menstrual period) 2. A dual-energy X-ray absorptiometry (DEXA) scan-based T-score of the lumbar spine (L1-L4) of less than -1.49 (i.e. a normal value according to the World Health Organization) 3. Body mass index (BMI) between 18 and 30 4. Vitamin 25 (OH)D levels between 31-50 ng/mL Exclusion Criteria: 1. The last menstrual period less than 2 or more than 5 years before study recruitment 2. BMI under 18 or above 30 3. Oral or transdermal hormone therapy with estrogens and/or progestogens within the last 6 months 4. Corticosteroid or thyroid hormone therapy within the last 6 months 5. History of osteopenia or osteoporosis 6. Neoplastic disease treated with cytostatic agents within the last 12 months 7. Autoimmune disorders, including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis; malabsorption syndromes, including celiac disease; chronic kidney disease; chronic liver failure; endocrine disorders, including Hashimoto thyroiditis, Graves' disease, Cushing disease or syndrome, hyperparathyroidism, hypogonadism, hyperprolactinemia, acromegaly, diabetes mellitus; and other chronic conditions affecting bone metabolism 8. Antibiotic therapy within the last 2 months prior to study recruitment 9. Probiotic use within the last 2 months prior to study recruitment 10. Calcium and vitamin D supplementation within the 2 months prior to study recruitment 11. Treatment with antidepressant or antipsychotic agents involving a change of the agents or dosage within the last 3 months 12. Substance use disorder (alcohol, drugs, nicotine) 13. History of organ transplantation 14. Exposure to the SARS-Cov-2 virus within 14 days prior to study recruitment (based on patient declaration) 15. An acute COVID-19 infection within 14 days prior to study recruitment (based on patient declaration) 16. A surgical procedure scheduled to take place during this study 17. Participation in another study within the last 6 months 18. Inability to give an informed consent in writing 19. Any disease or circumstances that, according to the Investigator or Sponsor, might prevent the subject from completing the study or following study procedures and requirements

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinical Research Center

    Poznan, 60-773, Poland

  • Private Specialist Practice

    Bytom, 41-902, Poland

  • Specialist Practice

    Katowice, 40-750, Poland

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