Osteoporosis, Postmenopausal Clinical Trial
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
Verified date | April 2024 |
Source | Nordic Biotic Sp. z o.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 170 |
Est. completion date | June 15, 2024 |
Est. primary completion date | January 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Private Specialist Practice | Bytom | |
Poland | Specialist Practice | Katowice | |
Poland | Clinical Research Center | Poznan |
Lead Sponsor | Collaborator |
---|---|
Nordic Biotic Sp. z o.o. |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | From baseline and after 12 months of intervention | |
Secondary | Changes in the level of calcium | The level of calcium will be measured in serum and expressed in mg/dL. | From baseline and after 6 and 12 months of intervention | |
Secondary | Changes in the level of phosphorus | The level of phosphorus will be measured in serum and expressed in mg/dL. | From baseline and after 6 and 12 months of intervention | |
Secondary | Changes in the level of alkaline phosphatase | 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 | |
Secondary | Changes in the level of vitamin D | The level of vitamin D will be measured in serum and expressed in ng/mL. | From baseline and after 12 months of intervention | |
Secondary | Changes in the level of C-reactive protein | 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 | |
Secondary | Changes in Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m2. | From baseline and after 6 and 12 months of intervention | |
Secondary | 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. | From baseline for 12 months of intervention in 1 month intervals | |
Secondary | 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. | From baseline for 12 months of intervention in 1 month intervals | |
Secondary | 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. | From baseline for 12 months of intervention in 1 month intervals | |
Secondary | 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. | From baseline for 12 months of intervention in 1 month intervals | |
Secondary | Occurrence of adverse events | Adverse events will be recorded and described throughout the intervention period | For 12 months of intervention in 1 month intervals | |
Secondary | 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. | At months 2, 6, 10, and 12 of the intervention |
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