First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in parent quality of life (QoL) score
研究概览
简要总结
This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.
The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term healthy infant (37-41 weeks amenorrhea)
- •Birth weight >2750 g
- •Aged between 2 and 8 weeks
- •Presenting symptoms of infant colic as defined by Rome IV criteria by Zeevenhoven et al. 2017
- •Signed written informed consent of the parent/tutor
排除标准
- •Premature birth
- •Using probiotics as a treatment, different from the one that could contain the formula at the time of study recruitment
- •Acute or chronic illness as judged by the investigator which avoids the participation to the study .
- •Parents unable to understand the requirements of study participation as judged by the investigator
- •Malnutrition as judged by a body weight/height ratio <5 %
研究组 & 干预措施
Open label Bactecal® D Liquid 1 dose
Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
干预措施: Bactecal® D Liquid (Dietary Supplement)
Open label Bactecal® D Liquid 2 doses
Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.
干预措施: Bactecal® D Liquid (Dietary Supplement)
结局指标
主要结局
Change in parent quality of life (QoL) score
时间窗: Change from baseline parent QoL score at 28 days
By measuring parent quality of Life (QoL) score. Scale from 1 (minimum) to 7 (maximum). Higher scores mean a better outcome.
次要结局
- Change of the number of crying(Change from baseline number of crying at 28 days)
- Change of daily median crying time(Change from baseline daily median crying time at 28 days)