NCT01849185Unknown4 期
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- LDL-Cholesterol levels.
研究概览
简要总结
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.
排除标准
- •Patients on chronic antibiotic treatment
- •Patients with immune disorders
- •Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
- •Patients who experienced myocardial infarction within less than two months.
- •Patients who consume probiotics.
研究组 & 干预措施
BIO 25 (food supplements)twice a day for 8 weeks
Active Comparator
BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.
干预措施: Food supplement (Other)
Placebo twice a day for 8 weeks
Placebo Comparator
Placebo twice a day for 8 weeks
干预措施: Food supplement (Other)
结局指标
主要结局
LDL-Cholesterol levels.
时间窗: 8 weeks
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
次要结局
- Hemoglobin A1C(8 weeks)
研究者
研究点 (2)
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