NCT01067027Unknown4 期
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Children's Investigational Research Program, LLC2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
研究概览
简要总结
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ifants aged between 14 and 60 days
- •Breast fed, exclusively during length of trial
- •Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
- •Debut of colic symptoms 6+/-1 days before randomization
- •Gestational age between 37 and 42 weeks
- •Apgar score higher than 7 at 5 minutes
- •Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
- •Written informed consent from one or both parents
- •Stated availability throughout the study period
排除标准
- •Major chronic disease
- •Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
- •Administration of anitbiotics the week before randomization
- •Administration of probiotics the week before randomization
- •Participation in other clinical trials
结局指标
主要结局
* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
时间窗: 7, 14 and 21 days
次要结局
- Number of responders versus non-responders with L. reuteri versus placebo at end of the study.(21 days)
研究者
研究点 (2)
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