Status:
RECRUITING
Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Lead Sponsor:
a2 Milk Company Ltd.
Collaborating Sponsors:
Edanz Inc
Cyanth (Wuxi) Health Technology Co. Ltd.
Conditions:
Healthy Pregnant Women
Eligibility:
FEMALE
20-35 years
Phase:
NA
Brief 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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06980376
Start Date
August 25 2025
End Date
September 1 2026
Last Update
September 30 2025
Active Locations (5)
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1
Panyu Maternal and Child Care Service Centre of Guangzhou
Guangzhou, Guangdong, China, 511400
2
Wuxi Maternal and Child Health Hospital
Wuxi, Jiangsu, China, 214002
3
Affiliated hospital of Jiangnan University
Wuxi, Jiangsu, China, 214122
4
Xuzhou Maternal and Child Health Hospital
Xuzhou, Jiangsu, China, 221009