A2-only versus conventional UHT milk during pregnancy

Effects of Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes: A Multi-Centre, Randomised, Open-Label, Prospective Study

This trial will test whether drinking milk that contains only the A2 type of β-casein instead of regular A1/A2 UHT milk from early pregnancy through 40 days after birth reduces inflammation, improves digestive comfort, and affects infant birth outcomes in healthy pregnant women.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 35 Years
• Sex: Female
• Sponsor: a2 Milk Company Ltd. (Industry-sponsored)
• Locations: 6 sites (Foshan, Guangdong and 5 other locations)
• Trial ID: NCT06980376 on ClinicalTrials.gov

What this trial studies

Healthy pregnant women enrolled before 12 weeks' gestation are assigned to consume either conventional UHT milk containing both A1 and A2 β-caseins or a2 UHT milk containing only A2 β-casein from early pregnancy until 40 days after birth. Researchers will track markers of inflammation, self-reported gastrointestinal symptoms and tolerance, and infant birth outcomes. Key exclusions include cow's milk allergy or intolerance, BMI ≥35, significant systemic disorders, chronic medication use, recent probiotic use, or recent vaccination. The trial is sponsored by a2 Milk Company Ltd. and is conducted at three maternal and child health hospitals in Guangdong and Jiangsu provinces, China.

Who should consider this trial

Good fit: Ideal candidates are healthy pregnant women aged 20–35, recruited before 12 weeks' gestation with a singleton pregnancy, willing and able to drink milk and to deliver at one of the participating hospitals.

Not a fit: People with cow's milk allergy or intolerance, significant chronic medical conditions, BMI ≥35, or those taking chronic medications are excluded and unlikely to benefit from the intervention.

Why it matters

Potential benefit: If successful, switching to A2-only milk in pregnancy could reduce maternal inflammation and digestive symptoms and potentially improve some newborn outcomes.

How similar studies have performed: Some small adult studies report reduced self-reported digestive discomfort with A2-only milk compared with A1-containing milk, but evidence is limited and pregnancy-specific data are lacking.

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

Where this trial is running

Foshan, Guangdong and 5 other locations

• Foshan Maternity & Child Healthcare Hospital — Foshan, Guangdong, China (Recruiting)
• Panyu Maternal and Child Care Service Centre of Guangzhou — Guangzhou, Guangdong, China (Recruiting)
• Wuxi Maternal and Child Health Hospital — Wuxi, Jiangsu, China (Recruiting)
• Affiliated hospital of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)
• Xuzhou Maternal and Child Health Hospital — Xuzhou, Jiangsu, China (Recruiting)
• First People's Hospital of Chengdu — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Fen Xie

Conditions Healthy Pregnant Women