Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes

Launched by A2 MILK COMPANY LTD. · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different types of milk on pregnant women and their babies. One type is regular milk that contains both A1 and A2 proteins, while the other is a specially designed milk that only has the A2 protein. Researchers want to see how these milks affect inflammation, how well the body tolerates them, and the health of mothers and their babies from 12 weeks of pregnancy until 40 days after birth.

To participate in this trial, women need to be between 20 and 35 years old, pregnant with one baby, and willing to drink milk during their pregnancy. They should also be planning to give birth at the hospital where the study is taking place. However, if a woman has a high body weight, allergies to cow's milk, or other significant health issues, she may not be eligible to join. Participants can expect to drink one of the two types of milk and help researchers learn more about how these options might affect their health and their baby's health during and shortly after pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 20-35 years of age
• • Recruited at \<12 weeks of gestation
• • Intention to deliver at study site hospital
• • Singleton pregnancy
• • Able and willing to consume milk during pregnancy
• • Agree not to participate in another interventional clinical study during the present study
• Exclusion Criteria:
• • Body mass index ≥ 35 at enrolment
• • Cow's milk intolerance or allergy
• • Significant systemic disorder (e.g., cardiac, respiratory, endocrinological, hemato-logic, or GI); pre-pregnancy diabetes, hypertension, or other medical conditions that preclude participation per the investigator's judgement
• • Taking any prescribed chronic medications
• • Participation in another clinical trial
• • Investigator uncertainty about the willingness or ability of the participant to comply with the protocol requirements
• • Taking probiotics at screening or two weeks before enrolment
• • Receiving any vaccine at screening or two weeks before enrolment