Immune System Stimulation by Probiotic Food Supplementation
Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial
The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.
The incidence of flue and cold during the study period were compared between study groups.
Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- male or female between 25 to 45 years old;
- having caught the common cold or flu at least 4 to 6 times in the past calendar year;
- signed the informed consent forms before entering the study;
- fully understood the risks and potential benefits in participating this study.
Exclusion Criteria:
- were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
- having any gastrointestinal illness with medical treatment at the time of being enrolled;
- having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
- currently taking any pain killer drug;
- having received any vaccine for the upper respiratory infection within 6 months before enrollment;
- having received any purgative drug or digestion related drug within 2 weeks before enrollment;
- having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
- currently taking any preventive drug for upper respiratory infection;
- having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
- alcoholic or addicted to any drug;
- pregnant or breastfeeding mothers;
- having participated another clinical trial within 3 months before enrollment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Weiquan Yogurt with probiotics
Weiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml)
|
150 ml daily consumption for a total of 12 weeks
|
|
安慰剂比较：Weiquan Yogurt without probiotics
Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product.
|
150 ml daily consumption for a total of 12 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of flue symptoms during the study
大体时间：end of week 12
|
Body temperature≥38.0℃,
and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
|
end of week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of cold symptoms during the study
大体时间：end of week 12
|
Body temperature<38.0℃,
and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
|
end of week 12
|
|
Number of accumulated days of having cold symptoms during the study
大体时间：End of week 12
|
The total number of days of having one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite during the 12 week study period.
|
End of week 12
|
|
Serum IFN-γ concentration
大体时间：Baseline, end of week 12
|
Interferon gamma (unit: pg/ml)
|
Baseline, end of week 12
|
|
Serum IL-4 concentration
大体时间：Baseline, end of week 12
|
Interleukin 4 (unit: ng/ml)
|
Baseline, end of week 12
|
|
Serum IL-10 concentration
大体时间：Baseline, end of week 12
|
Interleukin 10 (unit: pg/ml)
|
Baseline, end of week 12
|
|
Serum IgA concentration
大体时间：Baseline, end of week 12
|
Immunoglobulin A (unit: g/L)
|
Baseline, end of week 12
|
|
Serum IgG concentration
大体时间：Baseline, end of week 12
|
Immunoglobulin G (unit: g/L)
|
Baseline, end of week 12
|
|
Serum IgM concentration
大体时间：Baseline, end of week 12
|
Immunoglobulin M (unit: g/L)
|
Baseline, end of week 12
|
|
Fecal sIgA concentration
大体时间：Baseline, end of week 12
|
Secretory Immunoglobulin A (unit: ng/ml)
|
Baseline, end of week 12
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 15-SC-09-WQ-002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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