Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
- Conditions
- Digestive System DiseaseCryingSleepiness
- Interventions
- Dietary Supplement: Conventional Milk (Weidendorf)Dietary Supplement: a2 Full Cream Milk
- Registration Number
- NCT05829720
- Lead Sponsor
- a2 Milk Company Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Milk (Weidendorf) Conventional Milk (Weidendorf) Conventional Milk (Weidendorf), 200ml/bag,per 100ml serving Nutrient Composition Energy: 267 kcal Protein:3.3g Fat:3.5g Carbohydrate:4.8g Sodium:50mg Calcium:120mg a2 Full Cream Milk a2 Full Cream Milk a2 Full Cream Milk, 200ml/bag, per 100ml serving Nutrient Composition Energy: 250 kcal Protein:3.2g Fat:3.3g Carbohydrate:4.3g Sodium:40mg Calcium:104mg
- Primary Outcome Measures
Name Time Method Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score 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 After 14 days of supplementation (T14) Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14
- Secondary Outcome Measures
Name Time Method Number of Hours of Infants Sleeping baseline day, to day 14 Number of Hours of Infants Sleeping Daily
Infant Crying Frequency baseline day, to day 14 The Frequency of Infant Crying Daily
Trial Locations
- Locations (2)
Jinhua Wenrong Hospital
🇨🇳Jinhua, Zhejiang, China
Qiu Bin Community Hospital
🇨🇳Jinhua, Zhejiang, China