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

Not Applicable

Recruiting

• Conditions: Healthy Pregnant Women

• Registration Number: NCT06980376
• Lead Sponsor: a2 Milk Company Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-20
• Status Verified: 2025-08
• Study Start: 2025-08-25
• Last Update Submitted: 2025-08-30
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IL-4	Visit 3 (36 weeks' gestation)	Blood IL-4 levels
GI tolerance	Visit 4 (40 days after delivery)	GI tolerance via the GSRS questionnaire

Secondary Outcome Measures

Name	Time	Method
pregnancy complications	Visit 4 (40 days after delivery)	Incidence of pregnancy complications
Vitamin D	Visit 3 (36 weeks' gestation)	Blood vitamin D levels
GSH levels	Visit 3 (36 weeks' gestation)	Blood GSH levels
IgG levels	Visit 3 (36 weeks' gestation)	Blood IgG levels
IL-1 levels	Visit 3 (36 weeks' gestation)	Blood IL-1 levels
hsCRP	Visit 3 (36 weeks' gestation)	Blood hsCRP levels
TNF-α	Visit 3 (36 weeks' gestation)	Blood TNF-α levels
Breastmilk composition	Visit 4 (40 days after delivery)	Breastmilk composition analyssis including metal ion testing, proteins, fats and HMOs
Infant birth outcomes	Visit 4 (40 days after delivery)	Infant birth outcomes, including anthropometric measurements (weight, length, head circumference, z-scores, Apgar score)
infant GI signs and symptoms	Visit 4 (40 days after delivery)	infant GI signs and symptoms assessed by IGSQ questionnaire
Adverse events	Visit 4 (40 days after delivery)	Record adverse events

Trial Locations

Locations (5)

Panyu Maternal and Child Care Service Centre of Guangzhou; 🇨🇳 Guangzhou, Guangdong, China

Wuxi Maternal and Child Health Hospital; 🇨🇳 Wuxi, Jiangsu, China

Xuzhou Maternal and Child Health Hospital; 🇨🇳 Xuzhou, Jiangsu, China

First People's Hospital of Chengdu; 🇨🇳 Chengdu, Sichuan, China

Affiliated hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China