Safety and Efficacy of Lactobacillus Reuteri DSM 17938 to Reduce the Crying Time in Infants With Colic: Randomised Controlled Trial With Two Parallel Arms. Version 3.3. Nov,11th,2016
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Crying time
研究概览
简要总结
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)
详细描述
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Children allocated on different arms will receive drops of probiotics or placebo. Both product are identical in appearence and flavor
入排标准
- 年龄范围
- 1 Week 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Younger than 10 weeks of age
- •Full term infant (37-42 weeks gestational age)
- •Birth weight ≥ 2,500g
- •Apgar score ≥ 7 at 5 minutes
- •Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
- •Parental motivation to postpone changes in the infant feeding mode, unless necessary
- •Stated availability throughout the study period
- •Parent(s) willingness and ability to fill out charts and questionnaires
- •Signed informed consent
排除标准
- •Failure to thrive
- •Chronic illness or major medical problem
- •Gastrointestinal disease
- •Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
- •Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
- •Use of proton pump inhibitors in the week (7 days) prior to enrolment
- •If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period
- •Use of infant formula with hydrolysed protein
- •Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
- •Change of feeding mode planned by parents during the study period
结局指标
主要结局
Crying time
时间窗: 21 days
Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.
次要结局
- Crying and fussing(7,14 and 21 days)
- Preliminary crying time(Day 7 and 14)
- Impact on Quality of Life(7, 14 and 21 days)
- Total responders(7,14 and 21 days)
- Maternal depression(7, 14 and 21 days)
研究者
Pedro Gutierrez Castrellon
MD, MSc, DSc
Innovacion y Desarrollo de Estrategias en Salud