Investigate Effects of a2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Digestive System Disease, Sleepiness, Crying

Intervention / Treatment
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* Dietary Supplement: a2 Full Cream Milk
* Dietary Supplement: Conventional Milk (Weidendorf)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a2 Full Cream Milk<br>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 | Dietary Supplement: a2 Full Cream Milk<br>* 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.<br>|
| Active Comparator: Conventional Milk (Weidendorf)<br>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 | Dietary Supplement: Conventional Milk (Weidendorf)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | After 14 days of supplementation (T14) | 
| Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score | Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60 | Baseline (T0) | 
| Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score | Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score, range 10 to 60 | After 14 days of supplementation (T14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Crying Frequency | The Frequency of Infant Crying Daily | baseline day, to day 14 | 
| Number of Hours of Infants Sleeping | Number of Hours of Infants Sleeping Daily | baseline day, to day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A2 Full Cream Milk, Breastmilk Composition, Gut Health