Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Cow's Milk-related Symptoms
研究概览
简要总结
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.
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 randomized controlled pilot study, the effect on comfort during usage of goat-milk based infant formula is studied. Twenty formula fed infants (aged between 6 weeks and 3 months) who experience mild discomfort will receive goat milk-based infant formula (GMF) or cow's mik based infant formula supplemented with probiotics lactobacillus reuteri drops (CMFp). The infants will be assessed by a local paediatricians using the Cow's Milk-related Symptom Score (CoMiSS). This is a fast, non-invasive and easy-to-use and validated questionnaire to assess infant's reaction to proteins found in cow's milk. The higher the score, the more sensitive the child is to cow's milk proteins, the maximum score is 33 points. Infants with a CoMiSS Score between 6 and 12 will be enrolled in this study. It is expected that infants will have a better response to GMF, which will result in a decrease of the CoMiSS Score after a 2 weeks 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
- None
入排标准
- 年龄范围
- 6 Weeks 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
- •Infant aged between 4 weeks and 3 months at enrolment
- •CoMiSS value at baseline between 6 and 12
- •Infant is exclusively bottle fed with cow's milk based infant formula at baseline
排除标准
- •Breastfed infants
- •Congenital illness or malformation that may affect infant feeding or normal growth
- •Gastrointestinal disorders
- •Confirmed cow or goat milk protein allergy or lactose intolerance
- •Supplemental feeding
- •Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment
- •Infant participating in another clinical study
结局指标
主要结局
Cow's Milk-related Symptoms
时间窗: 0-2 weeks
Difference in Cow's Milk related Symptom Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 14 days of intervention.
次要结局
- Cow's Milk-related Symptoms(0-4 weeks)
- Weight(0-4 weeks)
- Weight-for-age(0-4 weeks)
- Length-for-age(0-4 weeks)
- Weight-for-length(0-4 weeks)
- Length(0-4 weeks)
- Parental stress(0-4 weeks)
- Parental quality of life(0-4 weeks)