Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

a2 Milk

Status: Completed

Conditions: Crying; Sleepiness; Digestive System Disease

Treatments: Dietary Supplement: a2 Full Cream Milk; Dietary Supplement: Conventional Milk (Weidendorf)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05829720

22-SM-12-A2-001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

a2 Full Cream Milk

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: a2 Full Cream Milk

Conventional Milk (Weidendorf)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Conventional Milk (Weidendorf)