NCT01315418终止不适用
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Danone Research2 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 239
- 试验地点
- 2
研究概览
简要总结
This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female aged 18-29 years
- •attending 7 weeks of firemen training school
- •a 19 to 29 kg/m2 body mass index
- •found medically healthy (in particular, free of respiratory and GI tract symptoms)
- •agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour.
排除标准
- •Subject who is not reading and writing French, or not understanding informed consent or study protocol
- •subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy;
- •subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes...) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease...)
- •subject having experienced any infectious disease during the last 7 days
- •subject with current diarrhoea or constipation
- •subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study
- •subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study
- •subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia, alcoholism...)
- •subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment...
- •subject already enrolled in another clinical study, or currently under an exemption period from a previous study
- •female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study
- •subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
研究者
研究点 (2)
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