Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Effects of Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes: A Multi-Centre, Randomised, Open-Label, Prospective Study
a2 Milk Company Ltd.
100 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
Summary
The aim of the study is to compare the effects of conventional Ultra High Temperature (UHT) milk containing both A1 and A2 type β-caseins (CON) with a2 UHT Milk containing A2 type β-casein only (A1PF) on inflammation, tolerance, and GI symptoms in pregnant women as well as infants' birth outcomes from 12 weeks' gestation up to 40 days post-birth.
Eligibility
Inclusion Criteria6
- -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 Criteria8
- 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
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Interventions
Pregnant women in this arm will drink a2 UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively.
Pregnant women in this arm will drink conventional UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06980376