Osteoporosis, PostmenopausalNCT06375668
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
A study testing Probiotic in people with Osteoporosis, Postmenopausal and Bone Density, Low, run by Nordic Biotic Sp. z o.o. at 3 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Bone Density, Low
- 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
- 170 participants
- Where
- 3 sitesPoland
- Study dates
- 15 Mar 2022to 15 Jun 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women (between 2 and 5 years after their last menstrual period)
- 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)
- Body mass index (BMI) between 18 and 30
- Vitamin 25 (OH)D levels between 31-50 ng/mL
Who cannot join
- The last menstrual period less than 2 or more than 5 years before study recruitment
- BMI under 18 or above 30
- Oral or transdermal hormone therapy with estrogens and/or progestogens within the last 6 months
- Corticosteroid or thyroid hormone therapy within the last 6 months
- History of osteopenia or osteoporosis
- Neoplastic disease treated with cytostatic agents within the last 12 months
Show all 19Show fewer
- 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
- Antibiotic therapy within the last 2 months prior to study recruitment
- Probiotic use within the last 2 months prior to study recruitment
- Calcium and vitamin D supplementation within the 2 months prior to study recruitment
- Treatment with antidepressant or antipsychotic agents involving a change of the agents or dosage within the last 3 months
- Substance use disorder (alcohol, drugs, nicotine)
- History of organ transplantation
- Exposure to the SARS-Cov-2 virus within 14 days prior to study recruitment (based on patient declaration)
- An acute COVID-19 infection within 14 days prior to study recruitment (based on patient declaration)
- A surgical procedure scheduled to take place during this study
- Participation in another study within the last 6 months
- Inability to give an informed consent in writing
- 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
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Private Specialist Practice
Bytom, 41-902
Specialist Practice
Katowice, 40-750
Clinical Research Center
Poznan, 60-773
About this study
Official title: 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.
Read the 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:
- 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;
- Randomization visit (visit 0) - subjects will be randomly allocated to study groups and will receive a supply of the study probiotic or placebo;
- 6 office visits (at months 2, 4, 6, 8, 10, and 12 of visit 0);
- 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:
- Complete blood count, erythrocyte sedimentation rate, and C-reactive protein levels (at screening and at months 6 and 12 of the study intervention);
- Serum calcium, phosphorus, and alkaline phosphatase levels (at screening and at months 6 and 12 of the study intervention);
- Serum vitamin D and parathormone levels (at screening and at month 12 of intervention).
- Conditions
- Osteoporosis, Postmenopausal, Bone Density, Low
- Being tested
- Probiotic, Placebo
- Keywords
- bone mineral density, osteoporosis, probiotics
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
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™).
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | A dietary supplement in the form of capsules containing probiotic bacterial strains. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo capsules with the same appearance and weight as probiotic capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intervention on bone mineral density
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).
Measured: From baseline and after 12 months of intervention
Secondary outcomes (12)
Changes in the level of calcium
The level of calcium will be measured in serum and expressed in mg/dL.
Measured: From baseline and after 6 and 12 months of intervention
Changes in the level of phosphorus
The level of phosphorus will be measured in serum and expressed in mg/dL.
Measured: From baseline and after 6 and 12 months of intervention
Changes in the level of alkaline phosphatase
The level of alkaline phosphatase will be measured in serum and expressed in U/L.
Measured: From baseline and after 6 and 12 months of intervention
Changes in the level of vitamin D
The level of vitamin D will be measured in serum and expressed in ng/mL.
Measured: From baseline and after 12 months of intervention
Changes in the level of C-reactive protein
The level of C-reactive protein will be measured in serum and expressed in mg/L.
Measured: From baseline and after 6 and 12 months of intervention
Changes in Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m2.
Measured: From baseline and after 6 and 12 months of intervention
Changes in type of stools
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.
Measured: From baseline for 12 months of intervention in 1 month intervals
Changes in the number of bowel movements
The number of bowel movements per day will be assessed as mean of bowel movements during the last 7 days before visit.
Measured: From baseline for 12 months of intervention in 1 month intervals
Changes in severity of abdominal pain
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.
Measured: From baseline for 12 months of intervention in 1 month intervals
Changes in severity of bloating
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.
Measured: From baseline for 12 months of intervention in 1 month intervals
Occurrence of adverse events
Adverse events will be recorded and described throughout the intervention period
Measured: For 12 months of intervention in 1 month intervals
Satisfaction with 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.
Measured: At months 2, 6, 10, and 12 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 Mar 2022
- Primary completion15 Jan 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna Głogowska-Szeląg, MD, PhD, Principal investigator, Private Specialist Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375668
- Sponsor's protocol ID
- CT/NB/140/2020/PR-MS
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glogowska-Szelag J, Palka-Kisielowska I, Porawska W, Bierla JB, Szczepankowska AK, Aleksandrzak-Piekarczyk T, Cukrowska B. The Effect of Lacticaseibacillus paracasei LPC100 and Lactiplantibacillus plantarum LP140 on Bone Mineral Density in Postmenopausal Women: A Multicenter, Randomized, Placebo-Controlled Study. J Clin Med. 2024 Oct 8;13(19):5977. doi: 10.3390/jcm13195977.
PubMed 39408038
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Probiotic Strains Lactobacillus Plantarum and Lactobacillus Paracasei on Bone Mineral Density in Postmenopausal Women - a Multicenter Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06375668
- Acronym / sponsor ID
- CT/NB/140/2020/PR-MS
- Conditions
- Osteoporosis, Postmenopausal, Bone Density, Low
- Keywords
- bone mineral density, osteoporosis, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 19 Apr 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.
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.
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:
- 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;
- Randomization visit (visit 0) - subjects will be randomly allocated to study groups and will receive a supply of the study probiotic or placebo;
- 6 office visits (at months 2, 4, 6, 8, 10, and 12 of visit 0);
- 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:
- Complete blood count, erythrocyte sedimentation rate, and C-reactive protein levels (at screening and at months 6 and 12 of the study intervention);
- Serum calcium, phosphorus, and alkaline phosphatase levels (at screening and at months 6 and 12 of the study intervention);
- Serum vitamin D and parathormone levels (at screening and at month 12 of intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticA dietary supplement in the form of capsules containing probiotic bacterial strains. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules with the same appearance and weight as probiotic capsules. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (between 2 and 5 years after their last menstrual period)
- 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)
- Body mass index (BMI) between 18 and 30
- Vitamin 25 (OH)D levels between 31-50 ng/mL
Key exclusion criteria (19 listed)
- The last menstrual period less than 2 or more than 5 years before study recruitment
- BMI under 18 or above 30
- Oral or transdermal hormone therapy with estrogens and/or progestogens within the last 6 months
- Corticosteroid or thyroid hormone therapy within the last 6 months
- History of osteopenia or osteoporosis
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 |
|---|---|---|
| ProbioticThe 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™). | Dietary supplement | Probiotic |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
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).
12 secondary outcomes
Changes in the level of calcium
Time frame: 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
Changes in the level of alkaline phosphatase
Time frame: 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
Changes in the level of C-reactive protein
Time frame: 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
Changes in type of stools
Time frame: 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
Changes in severity of abdominal pain
Time frame: 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
Occurrence of adverse events
Time frame: For 12 months of intervention in 1 month intervals
Satisfaction with the intervention
Time frame: At months 2, 6, 10, and 12 of the intervention
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 12 Mar 2026.
- Derived from this study: PubMed 39408038Glogowska-Szelag J, Palka-Kisielowska I, Porawska W, Bierla JB, Szczepankowska AK, Aleksandrzak-Piekarczyk T, Cukrowska B. The Effect of Lacticaseibacillus paracasei LPC100 and Lactiplantibacillus plantarum LP140 on Bone Mineral Density in Postmenopausal Women: A Multicenter, Randomized, Placebo-Controlled Study. J Clin Med. 2024 Oct 8;13(19):5977. doi: 10.3390/jcm13195977.
- 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.
Joanna Głogowska-Szeląg, MD, PhD principal investigator
Private Specialist Practice
3 sites 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 Osteoporosis, Postmenopausal and Bone Density, Low, run by Nordic Biotic Sp. z o.o. at 3 sites in Poland.
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 4 inclusion and 19 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
The effect of intervention on bone mineral density (time frame: From baseline and after 12 months of intervention). 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 NCT06375668, which also lists 1 linked publication.
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 12 Mar 2026.