Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Infant crying and fussing behaviour
研究概览
简要总结
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.
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)
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
- •Healthy, term infant from a singleton birth (=>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
排除标准
- •Infants with known genetic syndromes; birth weight (<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
研究组 & 干预措施
Experimental Infant Formula
Milk-based infant formula with prebiotics
干预措施: Experimental Infant formula (Other)
Reference group
Milk-based infant formula without prebiotics
干预措施: Reference group (Other)
结局指标
主要结局
Infant crying and fussing behaviour
时间窗: 6 weeks
As assessed by the Barr Baby Behavior Diary
次要结局
- Stool Microbiota(6 weeks)
- Stool calprotectin(6 weeks)
- Parent satisfaction(6 weeks)
- Infant behaviour(6 weeks)
- Infant stool patterns(6 weeks)
- Infant crying and fussing behaviour(6 weeks)
- Postnatal depression(6 weeks)
- Infant feeding patterns(6 weeks)
研究者
John Cairney
Professor
McMaster University