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Healthy Pregnant WomenNCT06980376

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

A study testing a2 UHT milk and Conventional UHT Milk in people with Healthy Pregnant Women, run by a2 Milk Company Ltd. at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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'… Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Pregnant Women
What is being tested?
a2 UHT milk and Conventional UHT Milk
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
6 sitesChina
Study dates
25 Aug 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • First People's Hospital of Chengdu

    Chengdu, Sichuan, 610041

  • Foshan Maternity & Child Healthcare Hospital

    Foshan, Guangdong, 528000

  • Panyu Maternal and Child Care Service Centre of Guangzhou

    Guangzhou, Guangdong, 511400

  • Wuxi Maternal and Child Health Hospital

    Wuxi, Jiangsu, 214002

  • Affiliated hospital of Jiangnan University

    Wuxi, Jiangsu, 214122

  • Xuzhou Maternal and Child Health Hospital

    Xuzhou, Jiangsu, 221009

Other trials in China

About this study

Official title: Effects of Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes: A Multi-Centre, Randomised, Open-Label, Prospective Study

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.

Being tested
a2 UHT milk, Conventional UHT Milk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT06980376
Study groupRoleWhat they receive
a2 UHT MilkActive comparatorcontaining A2 type β-casein only (A1PF)
Receives: Other: a2 UHT milk
Conventional UHT milkPlacebo comparatorcontaining both A1 and A2 type β-caseins (CON)
Receives: Other: Conventional UHT Milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GI tolerance

    GI tolerance via the GSRS questionnaire

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  2. GI tolerance

    GI tolerance via the GSRS questionnaire

    Measured: Visit 2 (24 weeks' gestation)

  3. GI tolerance

    GI tolerance via the GSRS questionnaire

    Measured: Visit 3 (36 weeks' gestation)

  4. GI tolerance

    GI tolerance via the GSRS questionnaire

    Measured: Visit 4 (40 days after delivery)

  5. IL-4

    Blood IL-4 levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  6. IL-4

    Blood IL-4 levels

    Measured: Visit 2 (24 weeks' gestation)

  7. IL-4

    Blood IL-4 levels

    Measured: Visit 3 (36 weeks' gestation)

Secondary outcomes (29)

  1. pregnancy complications

    Incidence of pregnancy complications

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  2. pregnancy complications

    Incidence of pregnancy complications

    Measured: Visit 2 (24 weeks' gestation)

  3. pregnancy complications

    Incidence of pregnancy complications

    Measured: Visit 3 (36 weeks' gestation)

  4. pregnancy complications

    Incidence of pregnancy complications

    Measured: Visit 4 (40 days after delivery)

  5. GSH levels

    Blood GSH levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  6. GSH levels

    Blood GSH levels

    Measured: Visit 2 (24 weeks' gestation)

  7. GSH levels

    Blood GSH levels

    Measured: Visit 3 (36 weeks' gestation)

  8. IgG levels

    Blood IgG levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  9. IgG levels

    Blood IgG levels

    Measured: Visit 2 (24 weeks' gestation)

  10. IgG levels

    Blood IgG levels

    Measured: Visit 3 (36 weeks' gestation)

  11. IL-1 levels

    Blood IL-1 levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  12. IL-1 levels

    Blood IL-1 levels

    Measured: Visit 2 (24 weeks' gestation)

  13. IL-1 levels

    Blood IL-1 levels

    Measured: Visit 3 (36 weeks' gestation)

  14. hsCRP

    Blood hsCRP levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  15. hsCRP

    Blood hsCRP levels

    Measured: Visit 2 (24 weeks' gestation)

  16. hsCRP

    Blood hsCRP levels

    Measured: Visit 3 (36 weeks' gestation)

  17. TNF-α

    Blood TNF-α levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  18. TNF-α

    Blood TNF-α levels

    Measured: Visit 2 (24 weeks' gestation)

  19. TNF-α

    Blood TNF-α levels

    Measured: Visit 3 (36 weeks' gestation)

  20. Vitamin D

    Blood vitamin D levels

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  21. Vitamin D

    Blood vitamin D levels

    Measured: Visit 2 (24 weeks' gestation)

  22. Vitamin D

    Blood vitamin D levels

    Measured: Visit 3 (36 weeks' gestation)

  23. Infant birth outcomes

    Infant birth outcomes, including anthropometric measurements (weight, length, head circumference, z-scores, Apgar score)

    Measured: Visit 4 (40 days after delivery)

  24. Breastmilk composition

    Breastmilk composition analyssis including metal ion testing, proteins, fats and HMOs

    Measured: Visit 4 (40 days after delivery)

  25. infant GI signs and symptoms

    infant GI signs and symptoms assessed by IGSQ questionnaire

    Measured: Visit 4 (40 days after delivery)

  26. Adverse events

    Record adverse events

    Measured: Visit 1 (baseline, 12 weeks' gestation)

  27. Adverse events

    Record adverse events

    Measured: Visit 2 (24 weeks' gestation)

  28. Adverse events

    Record adverse events

    Measured: Visit 3 (36 weeks' gestation)

  29. Adverse events

    Record adverse events

    Measured: Visit 4 (40 days after delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start25 Aug 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980376
Sponsor's protocol ID
A2MC-G2411-73081
Status last verified
Oct 2026
First submitted
12 May 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing a2 UHT milk and Conventional UHT Milk in people with Healthy Pregnant Women, run by a2 Milk Company Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GI tolerance (time frame: Visit 1 (baseline, 12 weeks' gestation)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06980376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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