NCT06980376

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) 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 6, 2026

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

May 12, 2025

Last Update Submit

February 4, 2026

Conditions

Healthy Pregnant Women

Outcome Measures

Primary Outcomes (7)

  • GI tolerance

    GI tolerance via the GSRS questionnaire

    Visit 1 (baseline, 12 weeks' gestation)

  • GI tolerance

    GI tolerance via the GSRS questionnaire

    Visit 2 (24 weeks' gestation)

  • GI tolerance

    GI tolerance via the GSRS questionnaire

    Visit 3 (36 weeks' gestation)

  • GI tolerance

    GI tolerance via the GSRS questionnaire

    Visit 4 (40 days after delivery)

  • IL-4

    Blood IL-4 levels

    Visit 1 (baseline, 12 weeks' gestation)

  • IL-4

    Blood IL-4 levels

    Visit 2 (24 weeks' gestation)

  • IL-4

    Blood IL-4 levels

    Visit 3 (36 weeks' gestation)

Secondary Outcomes (29)

  • pregnancy complications

    Visit 1 (baseline, 12 weeks' gestation)

  • pregnancy complications

    Visit 2 (24 weeks' gestation)

  • pregnancy complications

    Visit 3 (36 weeks' gestation)

  • pregnancy complications

    Visit 4 (40 days after delivery)

  • GSH levels

    Visit 1 (baseline, 12 weeks' gestation)

  • +24 more secondary outcomes

Study Arms (2)

a2 UHT Milk

ACTIVE COMPARATOR

containing A2 type β-casein only (A1PF)

Other: a2 UHT milk

Conventional UHT milk

PLACEBO COMPARATOR

containing both A1 and A2 type β-caseins (CON)

Other: Conventional UHT Milk

Interventions

a2 UHT milkOTHER

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.

a2 UHT Milk
Conventional UHT MilkOTHER

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.

Conventional UHT milk

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Foshan Maternity & Child Healthcare Hospital

Foshan, Guangdong, 528000, China

RECRUITING

Panyu Maternal and Child Care Service Centre of Guangzhou

Guangzhou, Guangdong, 511400, China

RECRUITING

Wuxi Maternal and Child Health Hospital

Wuxi, Jiangsu, 214002, China

RECRUITING

Affiliated hospital of Jiangnan University

Wuxi, Jiangsu, 214122, China

RECRUITING

Xuzhou Maternal and Child Health Hospital

Xuzhou, Jiangsu, 221009, China

RECRUITING

First People's Hospital of Chengdu

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Fen Xie

CONTACT

86 510 88682959jndxfygcp@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 6, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)