The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women

March 10, 2026 updated by: Nordic Biotic Sp. z o.o.

The Effect of the Probiotic Strains Lactobacillus Plantarum and Lactobacillus Paracasei on Bone Mineral Density in Postmenopausal Women - a Multicenter Randomized Placebo-controlled Study

Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main purpose of the study is to assess the effect of oral probiotic supplementation on bone mineral density in postmenopausal women. A total of 170 female subjects who meet all the inclusion criteria and none of the exclusion criteria are to be included and randomized to one of two arms (the probiotic arm or the placebo arm) at a ratio of 1:1.

The subjects who provide their written informed consent will receive oral probiotic formulation containing a mixture of two strains Lactobacillus plantarum and Lactobacillus paracasei or placebo. The probiotic formulation and placebo will be provided by Nordic Biotic Ltd. (the company will also ensure study drug blinding). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.

The study timeline spans 54 weeks and involves 13 visits, including:

  1. Screening visit - subjects eligibility to participate in the study will be assessed based on the inclusion/exclusion criteria - the screening period will last up to 14 before the study drug is administered;
  2. Randomization visit (visit 0) - subjects will be randomly allocated to study groups and will receive a supply of the study probiotic or placebo;
  3. 6 office visits (at months 2, 4, 6, 8, 10, and 12 of visit 0);
  4. 5 remote visits (at months 1, 3, 7, 9, and 11 of visit 0).

All subjects included in the study will undergo:

  • History-taking and physical examination at each office visit,
  • Nutritional status assessment (measurements of body weight and height, with a BMI calculation) at the screening visit and at months 6 and 12 of the study intervention,
  • Two densitometry scans (DEXA) of the lumbar segment of the spine (L1-L4) at the screening visit and at month 12 of visit 0,
  • Treatment satisfaction assessment (treatment satisfaction questionnaire) at months 2, 6, 10, and 12 of the study intervention.

At each visit, whether conducted at the doctor's office or remotely, subjects will be asked about their use of the study drug and any gastrointestinal symptoms (number of bowel movements, stool consistency, bloating, abdominal pain), and the use of any other medications (including antibiotics). Each time, the subjects will be also asked about any side effects. Stool consistency will be assessed with the Bristol Stool Form Scale, and abdominal pain, bloating, and nausea will be assessed with a 5-grade Likert scale.

Blood samples will be collected from all subjects during the screening period, after 6 months of intervention and at the completion of intervention (i.e. at month 12).

The following blood tests will be conducted:

  1. Complete blood count, erythrocyte sedimentation rate, and C-reactive protein levels (at screening and at months 6 and 12 of the study intervention);
  2. Serum calcium, phosphorus, and alkaline phosphatase levels (at screening and at months 6 and 12 of the study intervention);
  3. Serum vitamin D and parathormone levels (at screening and at month 12 of intervention).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bytom, Poland, 41-902
        • Private Specialist Practice
      • Katowice, Poland, 40-750
        • Specialist Practice
      • Poznan, Poland, 60-773
        • Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Probiotic
A dietary supplement in the form of capsules containing probiotic bacterial strains.
Dietary supplement: Probiotic
The patients who give their consent to take part in this study, will receive one time per day for a period of 12 month a capsule containing ten billions of Lactobacillus plantarum (LP 140 NORDBIOTIC™) and Lactobacillus paracasei (LPC 100 NORDBIOTIC™).
Placebo Comparator: Placebo
Placebo capsules with the same appearance and weight as probiotic capsules.
Other: Placebo
The patients who give their consent to take part in this study, will receive one time per day for a period of 12 months a capsule containing maltodextrin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effect of intervention on bone mineral density
Time Frame: From baseline and after 12 months of intervention
Bone mineral density (BMD) of the lumbar segment of the spine (L1-L4) will be measured by two densitometry scans (DEXA) and presented as T-score. T-score is measured in standard deviations and reflects the difference between the patient's measured BMD and the mean value of BMD in healthy, young, matched controls (30-year-old women).
From baseline and after 12 months of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with the intervention
Time Frame: At months 2, 6, 10, and 12 of the intervention
Satisfaction with the intervention will be assessed by a questionnaire consisting of 6 questions regarding satisfaction with the form of the preparation, ease of administration, benefits, and course of treatment on a scale of 1-7, with the higher the score, the higher the satisfaction.
At months 2, 6, 10, and 12 of the intervention
Changes in the level of calcium
Time Frame: From baseline and after 6 and 12 months of intervention
The level of calcium will be measured in serum and expressed in mg/dL.
From baseline and after 6 and 12 months of intervention
Changes in the level of phosphorus
Time Frame: From baseline and after 6 and 12 months of intervention
The level of phosphorus will be measured in serum and expressed in mg/dL.
From baseline and after 6 and 12 months of intervention
Changes in the level of alkaline phosphatase
Time Frame: From baseline and after 6 and 12 months of intervention
The level of alkaline phosphatase will be measured in serum and expressed in U/L.
From baseline and after 6 and 12 months of intervention
Changes in the level of vitamin D
Time Frame: From baseline and after 12 months of intervention
The level of vitamin D will be measured in serum and expressed in ng/mL.
From baseline and after 12 months of intervention
Changes in the level of C-reactive protein
Time Frame: From baseline and after 6 and 12 months of intervention
The level of C-reactive protein will be measured in serum and expressed in mg/L.
From baseline and after 6 and 12 months of intervention
Changes in Body Mass Index (BMI)
Time Frame: From baseline and after 6 and 12 months of intervention
Weight and height will be combined to report BMI in kg/m2.
From baseline and after 6 and 12 months of intervention
Changes in type of stools
Time Frame: From baseline for 12 months of intervention in 1 month intervals
The stool type will be assessed with the Bristol Stool Formation Scale. The Bristol Stool Formation Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
From baseline for 12 months of intervention in 1 month intervals
Changes in the number of bowel movements
Time Frame: From baseline for 12 months of intervention in 1 month intervals
The number of bowel movements per day will be assessed as mean of bowel movements during the last 7 days before visit.
From baseline for 12 months of intervention in 1 month intervals
Changes in severity of abdominal pain
Time Frame: From baseline for 12 months of intervention in 1 month intervals
The severity of pain will be assessed with a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain.
From baseline for 12 months of intervention in 1 month intervals
Changes in severity of bloating
Time Frame: From baseline for 12 months of intervention in 1 month intervals
The bloating will be assessed with a patient-defined 5 point Linkert scale: point 0 - no bloating, and 1-4 the severity of bloating with higher scores indicating worse bloating.
From baseline for 12 months of intervention in 1 month intervals
Occurrence of adverse events
Time Frame: For 12 months of intervention in 1 month intervals
Adverse events will be recorded and described throughout the intervention period
For 12 months of intervention in 1 month intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nordic Biotic Sp. z o.o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanna Głogowska-Szeląg, MD, PhD, Private Specialist Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT/NB/140/2020/PR-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis, Postmenopausal

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings