Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
NCT ID: NCT06980376
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-25
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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a2 UHT Milk
containing A2 type β-casein only (A1PF)
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
containing both A1 and A2 type β-caseins (CON)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
FEMALE
Yes
Sponsors
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Edanz Inc
UNKNOWN
Cyanth (Wuxi) Health Technology Co. Ltd.
UNKNOWN
Affilicated Hospital of Jiangnan University
UNKNOWN
Guangzhou Trials Medical
UNKNOWN
a2 Milk Company Ltd.
INDUSTRY
Responsible Party
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Locations
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Foshan Maternity & Child Healthcare Hospital
Foshan, Guangdong, China
Panyu Maternal and Child Care Service Centre of Guangzhou
Guangzhou, Guangdong, China
Wuxi Maternal and Child Health Hospital
Wuxi, Jiangsu, China
Affiliated hospital of Jiangnan University
Wuxi, Jiangsu, China
Xuzhou Maternal and Child Health Hospital
Xuzhou, Jiangsu, China
First People's Hospital of Chengdu
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A2MC-G2411-73081
Identifier Type: -
Identifier Source: org_study_id
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