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

NCT06980376 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-06

No results posted yet for this 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.

Conditions

  • Healthy Pregnant Women

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Edanz Inc

    collaborator UNKNOWN
  • Cyanth (Wuxi) Health Technology Co. Ltd.

    collaborator UNKNOWN
  • Affilicated Hospital of Jiangnan University

    collaborator UNKNOWN
  • Guangzhou Trials Medical

    collaborator UNKNOWN
  • a2 Milk Company Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980376 on ClinicalTrials.gov