NCT01677702已完成不适用
The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization
Inner Mongolia Yili Industrial Group Co., Ltd2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Assess occurrence of flu symptoms during intervention
研究概览
简要总结
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 to 12 years, catch cold for 4 to 6 times in last year;
- •Age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month;
- •Age 60 to 75 years, catch cold for 4 to 6 times in last year;
- •BMI 18.5to 29.9kg/m2;
- •Able to understand the nature and purpose of the study including potential risks and side effects
排除标准
- •Recent (within 6 months of screening) been vaccinated influenza vaccine, or recent (within 15 days of screening) been vaccinated ther vaccines;
- •Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
- •Long-term use of any prescription or OTC medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin C;
- •Recent use (within 3 months of screening) of any prescription or OTC medication that significantly affects immune response, such as antibiotic;
- •Known allergies to dairy and any substance in the study product;
- •History of alcohol, drug, or medication abuse
- •Pregnant or breastfeeding women
- •Recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt;
- •Any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
结局指标
主要结局
Assess occurrence of flu symptoms during intervention
时间窗: 3 months
次要结局
- Assess severity of flu symptoms(3 months)
- Proportion of subjects which require treatment with flu medication(3 months)
- Change in immune markers such as antibodies and interleukins(Baseline & 3 months)
- Record subject sick leave due to flu(3 months)
研究者
研究点 (2)
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