NCT01200173已完成不适用
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Danone Research2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2006年11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
- 600
- 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) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject whose parents/legal guardians had given written informed consent,
- •Male or female, aged 3 to 6 years (upper bound excluded),
- •Attending day-care centres or preschools 5 days a week in the Moscow area,
- •Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
- •Subject who appreciated dairy products and multi-fruit flavour.
排除标准
- •Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
- •Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), 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 could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive...).
- •Subject having experienced any infectious disease during the last 7 days.
- •Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had 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...).
- •Subject currently receiving, or who had 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 antiinflammatory substances, immunosuppressant treatment...
- •Subject already enrolled in another clinical study, or currently under an exemption period from a previous 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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