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Clinical Trials in China / NCT06980376
Active, not recruiting Not applicable

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

NCT06980376 · tracked via the Priya Life Science China tracker
Sponsor
a2 Milk Company Ltd.
Phase
Not applicable
Started
2025-08-25
Last updated
2026-07-07

Condition(s) studied

Healthy Pregnant Women

Investigational drug(s) / intervention(s)

a2 UHT milkConventional UHT Milk

a2 UHT milk: 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.

Conventional UHT Milk: 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.

Study 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

Sex
FEMALE
Min age
20 Years
Max age
35 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Foshan Maternity & Child Healthcare Hospital Foshan Guangdong
Panyu Maternal and Child Care Service Centre of Guangzhou Guangzhou Guangdong
Wuxi Maternal and Child Health Hospital Wuxi Jiangsu
Affiliated hospital of Jiangnan University Wuxi Jiangsu
Xuzhou Maternal and Child Health Hospital Xuzhou Jiangsu
First People's Hospital of Chengdu Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980376 on ClinicalTrials.gov ↗ ← All trials in China