Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- BioGaia AB
- 试验地点
- 1
- 主要终点
- Daily average of crying time with L reuteri vs placebo
研究概览
简要总结
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
详细描述
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.
Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •otherwise healthy infants
- •Infantile colic according to Roe IV criteria
- •Full term infants
- •Birth weight 2500 - 4000g
- •Exclusively breast milk or partially breastfed
- •Mothers last education degree is Senior high school
排除标准
- •Clinically suspected allergy
- •Consumption of probiotics, antibiotics, PPI
- •Failure to thrive
研究组 & 干预措施
Placebo
Oils drops
干预措施: Placebo (Dietary Supplement)
Lactobacillus reuteri DSM17938
Oil drops
干预措施: Lactobacillus reuteri DSM17938 (Dietary Supplement)
结局指标
主要结局
Daily average of crying time with L reuteri vs placebo
时间窗: Day 28
Daily crying diary
Daily average of crying time with L reuteri vs placebo
时间窗: Day 21
Daily crying diary
Daily average of crying time with L reuteri vs placebo
时间窗: day 7
Daily crying diary
Daily average of crying time with L reuteri vs placebo
时间窗: Day 14
Daily crying diary
次要结局
- Number of responder vs non-responders(baseline, day 7, 14, 21, 28)
- Reduction of daily average crying time(baseline, day 7, 14, 21, 28)
- Parents perception of colic severity (Diary)(baseline, day 7, 14, 21, 28)
- Parents/Family quality of life (Diary)(baseline, day 7, 14, 21, 28)
- Parental satisfactory (Diary)(baseline, day 7, 14, 21, 28)