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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
Mothers in this arm will drink a2 Full Cream Milk twice a day, 200ml each time, for 14 consecutive days. Infants in this arm will be fed with mather's breastmilk exclusively.
Mothers in this arm will drink Conventional Milk (Weidendorf) twice a day, 200ml each time, for 14 consecutive days. Infants in this arm will be fed with mather's breastmilk exclusively.
Jinhua Wenrong Hospital
Jinhua, Zhejiang, China
Qiu Bin Community Hospital
Jinhua, Zhejiang, China
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on baseline day
Time frame: Baseline (T0)
Breast milk excretion of Human Milk oligosaccharide content (HMO) content
Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on day 14
Time frame: After 14 days of supplementation (T14)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Time frame: Baseline (T0)
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60
Time frame: After 14 days of supplementation (T14)
Infant Crying Frequency
The Frequency of Infant Crying Daily
Time frame: baseline day, to day 14
Number of Hours of Infants Sleeping
Number of Hours of Infants Sleeping Daily
Time frame: baseline day, to day 14
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