NCT06375668Completed
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
The Effect of the Probiotic Strains Lactobacillus Plantarum and Lactobacillus Paracasei on Bone Mineral Density in Postmenopausal Women - a Multicenter Randomized Placebo-controlled Study
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 170 (actual)
- First submitted
- 16 Apr 2024
- Start date
- 15 Mar 2022
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Diseases
- Osteoporosis
- NCT number
- NCT06375668
What you commit to
- Study type: Interventional
- Participants enrolled: 170
- From 15 Mar 2022 to the primary completion date, 15 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Neoplastic disease treated with cytostatic agents within the last 12 months
- Antibiotic therapy within the last 2 months prior to study recruitment
- Probiotic use within the last 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
- 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
Other illness
- History of osteopenia or osteoporosis
- 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
- Substance use disorder (alcohol, drugs, nicotine)
- History of organ transplantation
- 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
Lab values
- Calcium and vitamin D supplementation within the 2 months prior to study recruitment
Other
- The last menstrual period less than 2 or more than 5 years before study recruitment
- BMI under 18 or above 30
- Participation in another study within the last 6 months
- Inability to give an informed consent in writing
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Private Specialist Practice Coordinator of this site? Confirm its status | Bytom | Poland | Unknown status |
| Specialist Practice Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Clinical Research Center Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.