A Double-blind, Parallel Designed, Randomized Controlled Trial to Investigate Effects of Conventional Vs A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
研究概览
简要总结
The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.
50 mothers and thier infants will be enrolled into 2 study sites, mother and her child as one subject will be randomized to 2 groups for assigned interventions, a2 Full Cream Milk and conventional Milk (Weidendorf). The study will continue for 14 days, and 3 site visits will be made duing the study period. All data specified in the protocol will be captured and recorded into CTMS for analysis.
Researchers will compare the two groups of participants to see if a2 Full Cream Milk has significantly better breastmilk composition and improve infant's gut health, crying frequency and sleep patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers who are 25 to 45 years old;
- •Mothers who are exclusively breastfeeding with healthy and full-term infants;
- •Infants of these mothers who have been exclusively breastfed since birth, and their parent(s) decides to continue exclusively breastfeeding until at least 120 days of age, birth weight between 2500g and 4500g;
- •Willing to sign ICF before the study launched.
排除标准
- •Mothers with infection or have recently taken the flu / covid vaccine in the last 4 weeks;
- •Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey;
- •Evidence of feeding difficulties or intolerance/allergy to cow's milk (mixed-fed group only);
- •Conditions requiring infant feedings other than those specified in the protocol;
- •Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other); or parental refusal to participate;
- •Infants with an acute infection or gastroenteritis at time of enrollment;
- •Participation in another clinical trial;
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
结局指标
主要结局
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
时间窗: After 14 days of supplementation (T14)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
时间窗: After 14 days of supplementation (T14)
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14
次要结局
- Number of Hours of Infants Sleeping(baseline day, to day 14)
- Infant Crying Frequency(baseline day, to day 14)