CTRI/2017/07/009072已完成2 期
Evaluation of the effect of Bacillus coagulans on pH and levels of Mutans streptococci, Lactobacilli in saliva and plaque
Unique Biotech Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque
研究概览
简要总结
This study is a randomized, double blind, parallel group, uni-centre placebo controlled trail to evaluate the effect of 1 billion and 2 billion counts of Bacillus Coagulans daily for 14 days on pH, levels of Mutans Streptococci and Lactobacilli in saliva and plaque that will be conducted in India. The primary outcome will be the reduction of the levels of Mutans Streptococci and Lactobacilli and neutralisation of pH in saliva and plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Had not taken antibiotic or probiotic in any form within 2 weeks prior to the study.
- •Who are willing to chew the tablet and participate in the study.
排除标准
- •Children with acute infections, systemic diseases, immune-compromising conditions and special children.
- •Those who are not willing to participate in the study.
结局指标
主要结局
Reduction in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque
时间窗: 6 Months
次要结局
- No change in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque(6 Months)
研究者
研究点 (1)
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