NCT01677715已完成不适用
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
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8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
- Change in constipation condition
研究概览
简要总结
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year, with low immunity;
- •Non-specific and/or moderate constipation;
- •Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
- •Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week);
- •Able to understand the nature and purpose of the study including potential risks and side effects;
- •Willing to consent to study participation and to comply with study requirements
排除标准
- •Diagnosed as immunity-low associated with chronic disease;
- •Diagnosed as chronic constipation;
- •Treated gastrointestinal symptoms;
- •Currently suffering from diarrhea;
- •Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
- •Treatment by analgesic such as aspirin and paracetamol;
- •Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
- •Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
- •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;
- •Recent inoculation (within 6 months of screening) of influenza vaccine, or other vaccine in 15 days;
- •History of alcohol, drug, or medication abuse;
- •Pregnant or breastfeeding women;
- •Participation in another study with any investigational product within 3 months of screening
- •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
Change in constipation condition
时间窗: Baseline & 3 months
Assess severity of flu symptoms
时间窗: 3 months
次要结局
- Change in immune markers such as antibodies and interleukins(Baseline & 3 months)
- Change in gut resident flora(Baseline & 3 months)
研究者
研究点 (2)
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