A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 4
- 主要终点
- Days with diarrhea
研究概览
简要总结
The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.
详细描述
The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the 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
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure.
- •Healthy children aged 1 to 4 years
- •No more breastfed.
- •Daily home cared and going to a selected pediatrician.
- •Parents must have a phone at home or a cellular phone to call the paediatrician.
- •No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.
- •Children not being intensive consumers of regular yoghurts
- •Parents are able to keep a daily record of symptoms and to administrate the study products.
排除标准
- •Vaccine administration within the last 3 months prior study start.
- •Used antibiotics within the last month
- •Congenital or chronic disease.
- •Any kind of immunodeficiency or allergy.
- •Acute infection or fever.
- •Significant illness within the two weeks prior to the start of the study.
研究组 & 干预措施
Heat-treated lactobacilli
One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months.
干预措施: heat-treated lactobacilli or placebo (Dietary Supplement)
Maltodextrin
One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months.
干预措施: heat-treated lactobacilli or placebo (Dietary Supplement)
结局指标
主要结局
Days with diarrhea
时间窗: during 5 months of study period
次要结局
- Severity of upper respiratory infections(during 5 months)
- Duration of upper respiratory infections(during 5 months)
- Severity of gastrointestinal infections(during 5 months)
- Number of episodes of upper respiratory infections(during 5 months)