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

NCT ID: NCT06980376

Last Updated: 2026-02-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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a2 UHT Milk

containing A2 type β-casein only (A1PF)

Group Type ACTIVE_COMPARATOR

a2 UHT milk

Intervention Type OTHER

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)

Group Type PLACEBO_COMPARATOR

Conventional UHT Milk

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Edanz Inc

UNKNOWN

Sponsor Role collaborator

Cyanth (Wuxi) Health Technology Co. Ltd.

UNKNOWN

Sponsor Role collaborator

Affilicated Hospital of Jiangnan University

UNKNOWN

Sponsor Role collaborator

Guangzhou Trials Medical

UNKNOWN

Sponsor Role collaborator

a2 Milk Company Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foshan Maternity & Child Healthcare Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Panyu Maternal and Child Care Service Centre of Guangzhou

Guangzhou, Guangdong, China

Site Status RECRUITING

Wuxi Maternal and Child Health Hospital

Wuxi, Jiangsu, China

Site Status RECRUITING

Affiliated hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status RECRUITING

Xuzhou Maternal and Child Health Hospital

Xuzhou, Jiangsu, China

Site Status RECRUITING

First People's Hospital of Chengdu

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fen Xie

Role: CONTACT

86 510 88682959

Facility Contacts

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Yao Fu

Role: primary

+86-757-22978072

Guoliang He

Role: primary

+86 20 3915 9963

Yan Sun

Role: primary

+86-510-68004318

Fen Xie

Role: primary

86 510 88682959

Shuai Zhao

Role: primary

+85 516 8390 7537

Juan Zhou

Role: primary

+86 28 85223984

Other Identifiers

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A2MC-G2411-73081

Identifier Type: -

Identifier Source: org_study_id

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