NCT00635388已完成不适用
A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2008年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Number of healthy days.
研究概览
简要总结
The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be in good general health as reported by their parent(s)/legal guardian;
- •Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
- •Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)
排除标准
- •Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)
研究组 & 干预措施
1
Sham Comparator
干预措施: Placebo (Other)
2
Experimental
干预措施: Lactobacillus (Probiotic 1) (Other)
3
Experimental
干预措施: Lactobacillus and Bifidobacterium (Probiotic 2) (Other)
结局指标
主要结局
Number of healthy days.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pilot Study of Vitamin D Supplementation in Heart FailureHeart FailureNCT01388855Fraser Health13
已完成
2 期
A Pilot Study to Evaluate the Lipid Effects of TRIA-662HypertriglyceridemiaMixed HyperlipidemiaNCT02008084Cortria Corporation71
进行中（未招募）
2 期
Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 DiabetesObeseOverweightType 2 DiabetesNCT04797442Shanghai Jiao Tong University School of Medicine60
已完成
3 期
RCT for Pregabalin in Restless Legs Syndrome in South KoreaRestless Legs SyndromeNCT04161027Seoul National University Hospital116
尚未招募
3 期
Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal CancerRefractory Metastatic Colorectal CancerNCT06343116Biotech Pharmaceutical Co., Ltd.420