The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women (NCT06375668) | Clinical Trial Compass
CompletedNot Applicable
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
Poland170 participantsStarted 2022-03-15
Plain-language 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. 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.
Who can participate
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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
What they're measuring
1
The effect of intervention on bone mineral density
Timeframe: From baseline and after 12 months of intervention