Clinical trial NCT06980376: Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Pregnant Women
Lead sponsor: a2 Milk Company Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Edanz Inc
name: Cyanth (Wuxi) Health Technology Co. Ltd.
name: Affilicated Hospital of Jiangnan University
name: Guangzhou Trials Medical
First posted: 2025-05-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: GI tolerance
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: GI tolerance
timeFrame: Visit 2 (24 weeks' gestation)
measure: GI tolerance
timeFrame: Visit 3 (36 weeks' gestation)
measure: GI tolerance
timeFrame: Visit 4 (40 days after delivery)
measure: IL-4
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: IL-4
timeFrame: Visit 2 (24 weeks' gestation)
measure: IL-4
timeFrame: Visit 3 (36 weeks' gestation)
Secondary outcomes:
measure: pregnancy complications
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: pregnancy complications
timeFrame: Visit 2 (24 weeks' gestation)
measure: pregnancy complications
timeFrame: Visit 3 (36 weeks' gestation)
measure: pregnancy complications
timeFrame: Visit 4 (40 days after delivery)
measure: GSH levels
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: GSH levels
timeFrame: Visit 2 (24 weeks' gestation)
measure: GSH levels
timeFrame: Visit 3 (36 weeks' gestation)
measure: IgG levels
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: IgG levels
timeFrame: Visit 2 (24 weeks' gestation)
measure: IgG levels
timeFrame: Visit 3 (36 weeks' gestation)
measure: IL-1 levels
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: IL-1 levels
timeFrame: Visit 2 (24 weeks' gestation)
measure: IL-1 levels
timeFrame: Visit 3 (36 weeks' gestation)
measure: hsCRP
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: hsCRP
timeFrame: Visit 2 (24 weeks' gestation)
measure: hsCRP
timeFrame: Visit 3 (36 weeks' gestation)
measure: TNF-α
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: TNF-α
timeFrame: Visit 2 (24 weeks' gestation)
measure: TNF-α
timeFrame: Visit 3 (36 weeks' gestation)
measure: Vitamin D
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: Vitamin D
timeFrame: Visit 2 (24 weeks' gestation)
measure: Vitamin D
timeFrame: Visit 3 (36 weeks' gestation)
measure: Infant birth outcomes
timeFrame: Visit 4 (40 days after delivery)
measure: Breastmilk composition
timeFrame: Visit 4 (40 days after delivery)
measure: infant GI signs and symptoms
timeFrame: Visit 4 (40 days after delivery)
measure: Adverse events
timeFrame: Visit 1 (baseline, 12 weeks' gestation)
measure: Adverse events
timeFrame: Visit 2 (24 weeks' gestation)
measure: Adverse events
timeFrame: Visit 3 (36 weeks' gestation)
measure: Adverse events
timeFrame: Visit 4 (40 days after delivery)
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated hospital of Jiangnan University
state: Jiangsu
Study officials:
References: