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Active, Not Recruiting

NCT Number: NCT06980376

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Pregnant Women

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Foshan Maternity & Child Healthcare Hospital, Foshan, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a2 UHT milk

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

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.

Primary outcomes

  1. GI tolerance

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    GI tolerance via the GSRS questionnaire

  2. GI tolerance

    Time frame: Visit 2 (24 weeks' gestation)

    GI tolerance via the GSRS questionnaire

  3. GI tolerance

    Time frame: Visit 3 (36 weeks' gestation)

    GI tolerance via the GSRS questionnaire

  4. GI tolerance

    Time frame: Visit 4 (40 days after delivery)

    GI tolerance via the GSRS questionnaire

  5. IL-4

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood IL-4 levels

  6. IL-4

    Time frame: Visit 2 (24 weeks' gestation)

    Blood IL-4 levels

  7. IL-4

    Time frame: Visit 3 (36 weeks' gestation)

    Blood IL-4 levels

Secondary outcomes

  1. pregnancy complications

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Incidence of pregnancy complications

  2. pregnancy complications

    Time frame: Visit 2 (24 weeks' gestation)

    Incidence of pregnancy complications

  3. pregnancy complications

    Time frame: Visit 3 (36 weeks' gestation)

    Incidence of pregnancy complications

  4. pregnancy complications

    Time frame: Visit 4 (40 days after delivery)

    Incidence of pregnancy complications

  5. GSH levels

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood GSH levels

  6. GSH levels

    Time frame: Visit 2 (24 weeks' gestation)

    Blood GSH levels

  7. GSH levels

    Time frame: Visit 3 (36 weeks' gestation)

    Blood GSH levels

  8. IgG levels

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood IgG levels

  9. IgG levels

    Time frame: Visit 2 (24 weeks' gestation)

    Blood IgG levels

  10. IgG levels

    Time frame: Visit 3 (36 weeks' gestation)

    Blood IgG levels

  11. IL-1 levels

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood IL-1 levels

  12. IL-1 levels

    Time frame: Visit 2 (24 weeks' gestation)

    Blood IL-1 levels

  13. IL-1 levels

    Time frame: Visit 3 (36 weeks' gestation)

    Blood IL-1 levels

  14. hsCRP

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood hsCRP levels

  15. hsCRP

    Time frame: Visit 2 (24 weeks' gestation)

    Blood hsCRP levels

  16. hsCRP

    Time frame: Visit 3 (36 weeks' gestation)

    Blood hsCRP levels

  17. TNF-α

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood TNF-α levels

  18. TNF-α

    Time frame: Visit 2 (24 weeks' gestation)

    Blood TNF-α levels

  19. TNF-α

    Time frame: Visit 3 (36 weeks' gestation)

    Blood TNF-α levels

  20. Vitamin D

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Blood vitamin D levels

  21. Vitamin D

    Time frame: Visit 2 (24 weeks' gestation)

    Blood vitamin D levels

  22. Vitamin D

    Time frame: Visit 3 (36 weeks' gestation)

    Blood vitamin D levels

  23. Infant birth outcomes

    Time frame: Visit 4 (40 days after delivery)

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

  24. Breastmilk composition

    Time frame: Visit 4 (40 days after delivery)

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

  25. infant GI signs and symptoms

    Time frame: Visit 4 (40 days after delivery)

    infant GI signs and symptoms assessed by IGSQ questionnaire

  26. Adverse events

    Time frame: Visit 1 (baseline, 12 weeks' gestation)

    Record adverse events

  27. Adverse events

    Time frame: Visit 2 (24 weeks' gestation)

    Record adverse events

  28. Adverse events

    Time frame: Visit 3 (36 weeks' gestation)

    Record adverse events

  29. Adverse events

    Time frame: Visit 4 (40 days after delivery)

    Record adverse events

Sponsors and collaborators

Lead sponsor

a2 Milk Company Ltd.

Industry

Collaborators

  • Affiliated Hospital of Jiangnan University
  • Cyanth (Wuxi) Health Technology Co. Ltd.
  • Edanz Inc
  • Guangzhou Trials Medical

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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