The Effect of the Probiotic Strains Lactobacillus Plantarum and Lactobacillus Paracasei on Bone Mineral Density in Postmenopausal Women - a Multicenter Randomized Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- The effect of intervention on bone mineral density
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Probiotic
A dietary supplement in the form of capsules containing probiotic bacterial strains.
干预措施: Probiotic (Dietary Supplement)
Placebo
Placebo capsules with the same appearance and weight as probiotic capsules.
干预措施: Placebo (Other)
结局指标
主要结局
The effect of intervention on bone mineral density
时间窗: 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).
次要结局
- Changes in the level of phosphorus(From baseline and after 6 and 12 months of intervention)
- Changes in the level of alkaline phosphatase(From baseline and after 6 and 12 months of intervention)
- Changes in severity of abdominal pain(From baseline for 12 months of intervention in 1 month intervals)
- Changes in the level of calcium(From baseline and after 6 and 12 months of intervention)
- Changes in the level of vitamin D(From baseline and after 12 months of intervention)
- Changes in the level of C-reactive protein(From baseline and after 6 and 12 months of intervention)
- Changes in Body Mass Index (BMI)(From baseline and after 6 and 12 months of intervention)
- Changes in type of stools(From baseline for 12 months of intervention in 1 month intervals)
- Changes in the number of bowel movements(From baseline for 12 months of intervention in 1 month intervals)
- Changes in severity of bloating(From baseline for 12 months of intervention in 1 month intervals)
- Occurrence of adverse events(For 12 months of intervention in 1 month intervals)
- Satisfaction with the intervention(At months 2, 6, 10, and 12 of the intervention)