TCTR20230326002已完成2 期
Effects of Multispecies Probiotic Supplementation on Serum Bone Turnover Markers in Postmenopausal Women with Osteopenia: A Randomized, Double-blind, Placebo-controlled Trial
Faculty of Medicine, Ramathibodi Hospital0 个研究点目标入组 40 人开始时间: 2023年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Our study has demonstrated that multispecies probiotic supplementation for 12 weeks in osteopenic postmenopausal women may retard the increase in serum bone resorption marker CTX by downregulating osteoclast-induced bone resorption without significant adverse effects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •Postmenopausal who are amenorrheic for at least 12 months with serum FSH greater than or equal to 40 IU/L or post bilateral oophorectomy, aged 45-70 years, diagnosed with osteopenia using BMD measurement by dual energy X-ray absorptiometry (DXA) with T-score between -1 and -2.5 at lumbar spine, total hip or femoral neck. These patients are supplemented with calcium 1,200 mg/d and Vitamin D2 20,000 Units per week and are asked to avoid food high in probiotics content with a limit of no more than once a week (i.e. milk, yoghurt, cheese, kimchi). All patients need to write and sign a written informed consent.
排除标准
- •Diagnosed with osteoporosis (BMD from DEXA scan T-score less than or equal to -2.5) at lumbar spine, total hip or femoral neck, history of fragility fracture, BMI <18 or > 35 kg/m2, have secondary causes of bone loss screened from history and physical examination such as
- •Metabolic bone disease or other chronic diseases such as renal or liver diseases, ischemic disease, diabetes mellitus, cancer, thyroid or parathyroid diseases, Vitamin D deficiency with serum 25(OH) vitamin D < 20 ng/ml, autoimmune diseases on immunosuppressants, GI diseases and eating disorders such as malabsorptive disorders, anorexia nervosa, bulimia nervosa, inflammatory bowel disease, or currently using drugs altering bone metabolism such as bisphosphonates, raloxifene, calcitonin, anabolic agent, growth hormone, parathyroid hormone, steroids, anticoagulant within past 3 months, history of using probiotics or supplements altering bone metabolism within 3 months. Patients who cannot give a written informed consent are excluded.
研究者
相似试验
进行中（未招募）
4 期
OsteoPreP: Food Supplements for Postmenopausal Bone HealthPostmenopausal OsteopeniaBone Loss, Age RelatedAge-Related SarcopeniaGlucose Metabolism DisordersAge-related Cognitive DeclineNCT05348694Australian Catholic University160
招募中
3 期
probiotics in Irritable bowel syndromeIrritable bowel syndromeIRCT20181231042191N1Islamic Azad University50
已完成
不适用
Effects of a probiotic intervention on cognitive symptoms and gut-brain biomarkers in multiple sclerosis (MS); a pilot study.ACTRN12622000631707niversity of Tasmania28
已完成
不适用
Clinical study carried out to investigate the efficacy of two probiotic formulates on irritable bowel syndromeIrritable bowel syndrome associated constipation (IBS-C)Digestive SystemISRCTN15032219Farcoderm S.R.L.150
招募中
不适用
OsteoPreP: food supplements for postmenopausal bone healthACTRN12621001171808Australian Catholic University160