Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Regurgitation
研究概览
简要总结
The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
详细描述
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter 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
- 5 Days 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- •Age of infant between 5 days and 5 months
- •Infant exclusively formula-fed at enrollment
- •Presenting regurgitation/spitting-up according to the parents' perception
- •Vandenplas score of at least 2 and maximum 5
- •Having obtained the subject's legal representative's written informed consent
排除标准
- •Previous antireflux treatment
- •Previous consumption of AR infant formula or external thickener
- •Previous consumption of a formula with L. reuteri
- •Cow's milk allergy symptoms according to medical decision
- •Congenital illness or malformation that may affect growth
- •Significant pre-natal and/or post-natal disease
- •Newborn whose parents / caregivers cannot be expected to comply with study procedures
- •Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
结局指标
主要结局
Regurgitation
时间窗: four weeks of treatment
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
次要结局
- Stool frequency(Four weeks treatment)
- compliance(four weeks intervention)
- Growth(Four weeks of treatment)
- Gastric empty rate(Four week treatment)
- Financial and non-financial burden(Four week treatment)
- Digestive tolerance(Four weeks treatment)
- Regurgitation score(Four weeks treatment)
研究者
Flavia Indrio
M.D.
University of Bari