NCT04891666已完成不适用
A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Reduction of blood lead levels
研究概览
简要总结
The study is a parallel, randomized, double-blind, placebo controlled clinical trial will evaluate the effect of Lactobacillus plantarum DSM 33464 on reduction of Blood lead levels and general well-being of children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects who meet all of the following selection criteria can participate in this study:
- •Children age 3-12 years
- •BLL 35-249 µg/L
- •Subjects, their parents or legal guardians are able and willing to comply with research guidance
- •Subject's parents or legal guardians sign written informed consent.
排除标准
- •Subjects who meet any of the following exclusion criteria may not participate in this study:
- •Diagnosed with nervous system diseases, genetic and metabolic diseases, endocrine diseases, lung diseases, severe or unstable cardiovascular diseases, clinically significant kidney or liver diseases, blood system diseases, any other clinically significant diseases and Other investigators judge that the participation of subjects in the study will increase the risk of the subjects' diseases;
- •History of infection or organ transplantation of human immunodeficiency virus or other acquired congenital immunodeficiency diseases;
- •Take probiotic products in the last two weeks
- •Known or suspected sensitivity or allergy to food or any constituents tested in the trial
- •Participation in another clinical trial or food study 4 weeks prior and during the trial
结局指标
主要结局
Reduction of blood lead levels
时间窗: 12 weeks
Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline
次要结局
- Reduction of blood lead levels(4 and 8 weeks)
- Reduction of urine lead levels(4, 8 and 12 weeks)
- Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood(4, 8 and 12 weeks)
研究者
研究点 (5)
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