NCT02722980已完成不适用
A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study Aiming to Evaluate the Efficacy on BMD and Safety of a Probiotic Product in a Population of Healthy Women in Early Post-menopausal Phase, During an Intervention Period of 12 Months
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
研究概览
简要总结
The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For inclusion in the study, subjects must fulfil the following criteria:
- •Willing and able to give written informed consent for participation in the study.
- •Healthy women in early post-menopausal phase (at least two [2] years but a maximum of 12 years since the last menstruation and at least one [1] year since the last intake of hormone replacement therapy).
- •BMI ≥ 18 and ≤ 30 at screening.
- •BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.
- •Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
- •Ability to understand and comply with the requirements of the study, as judged by the Investigator.
排除标准
- •Subjects must not enter the study if any of the following exclusion criteria are fulfilled:
- •Relevant history of >1 previous fracture after 50 years of age, as judged by the Investigator.
- •T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
- •History of metabolic bone disease.
- •Unstable weight (± five [5] kg) during the last six (6) months.
- •History of hyperthyroidism or unstable hypothyroidism.
- •Diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease (IBD), celiac disease or diabetes.
- •Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.
- •Gastric bypass surgery performed.
- •History of immunodeficiency or immunosuppressive treatment.
- •Chronic or acute diarrheal disease.
- •Recently diagnosed malignancy (within the last five [5] years).
- •Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.
- •Per-oral use of corticosteroids.
- •Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
- •Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)
- •Use of any bone-formation stimulating therapy (currently or during the last 12 months).
- •Use of antibiotics during the last two (2) months.
- •Frequent user of antibiotics (>2 courses during the last 12 months) due to inter-current infection episodes.
- •Smoking or use of nicotine-containing products (currently or during the last six [6] months).
- •History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator.
- •Consumption of alcohol within 24 hours prior to the Baseline Visit.
- •Participation in any other clinical interventional study during the last three (3) months.
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- •Known hypersensitivity to any of the ingredients in the IP or the placebo (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).
- •Blood or plasma donation within three (3) months prior to baseline.
研究组 & 干预措施
Placebo
Placebo Comparator
Capsules
干预措施: Placebo (Dietary Supplement)
Active
Active Comparator
Capsules.
干预措施: : Probiotic capsules (Dietary Supplement)
结局指标
主要结局
Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
时间窗: Change in BMD from baseline to 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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