Crying, Digestive System Disease, Sleepiness
Conditions
Keywords
A2 Full Cream Milk, Breastmilk Composition, Gut Health
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.
Interventions
DIETARY_SUPPLEMENTa2 Full Cream Milk
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.
DIETARY_SUPPLEMENTConventional Milk (Weidendorf)
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.
Sponsors
a2 Milk Company Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast milk excretion of Human Milk oligosaccharide content (HMO) content | Baseline (T0) | Qualitative analysis of Breast milk excretion of Human Milk oligosaccharide content (HMO) content on baseline day |
| Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score | Baseline (T0) | Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant Crying Frequency | baseline day, to day 14 | The Frequency of Infant Crying Daily |
| Number of Hours of Infants Sleeping | baseline day, to day 14 | Number of Hours of Infants Sleeping Daily |
Countries
China
Outcome results
None listed