NCT05829720

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: a2 Milk Company Ltd. · Industry
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Digestive System Disease
• Sleepiness
• Crying

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	a2 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_SUPPLEMENT	Conventional 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.

Timeline

• Start date: 2023-06-13
• Primary completion: 2023-08-17
• Completion: 2023-08-17
• First posted: 2023-04-26
• Last updated: 2024-11-04

Locations

2 sites across 1 country: China