Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Gastrointestinal symptoms
研究概览
简要总结
The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention.
详细描述
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this double-blind, randomized controlled trial, gastrointestinal comfort in infants fed goat milk-based infant formula (GMF) or cow's milk-based infant formula (CMF) was studied.
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks. Stool consistency, regurgitation frequency and crying duration were measured weekly using an adapted version of the Cow's Milk-related Symptom Score (CoMiSS®) where only the items for these scores were used. Blood hemoglobin levels were measured at the start and at the end of the intervention.
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
Double-blind
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age 37-42 weeks
- •3-12 months old at enrollment
- •should have consumed cow's milk-based products during the 48 hours prior to the baseline visit to exclude cow's milk allergic infants
排除标准
- •metabolic or chronic disease or congenital malformation, serious concurrent illness that would interfere with study treatment, (i.e. sepsis, pneumonia with respiratory failure, cardiac failure)
- •infant's parent(s) or primary caregiver(s) diagnosed with major depression
- •infant's weight for length at baseline >|3| z-score indexes according to WHO criteria
- •infants enrolled in another interventional clinical research study
- •infants diagnosed with cow's milk allergies
结局指标
主要结局
Gastrointestinal symptoms
时间窗: 24 weeks, measured weekly
Stool consistency, regurgitation frequency and crying duration as measured by an adapted Cow's Milk-related Symptom Score®, where a higher score indicates more severe symptoms.
次要结局
- WHO z-score of weight-for-length(24 weeks, measured monthly)
- WHO z-score of length-for-age(24 weeks, measured monthly)
- WHO z-score of weight-for-age(24 weeks, measured monthly)
- Blood hemoglobin levels(24 weeks, measured at start and end)
- WHO z-score of head circumference-for-age(24 weeks, measured monthly)