NCT06980376进行中（未招募）不适用
Effects of Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes: A Multi-Centre, Randomised, Open-Label, Prospective Study
a2 Milk Company Ltd.10 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月25日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- GI tolerance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
a2 UHT Milk
Active Comparator
containing A2 type β-casein only (A1PF)
干预措施: a2 UHT milk (Other)
Conventional UHT milk
Placebo Comparator
containing both A1 and A2 type β-caseins (CON)
干预措施: Conventional UHT Milk (Other)
结局指标
主要结局
GI tolerance
时间窗: Visit 4 (40 days after delivery)
GI tolerance via the GSRS questionnaire
IL-4
时间窗: Visit 3 (36 weeks' gestation)
Blood IL-4 levels
GI tolerance
时间窗: Visit 1 (baseline, 12 weeks' gestation)
GI tolerance via the GSRS questionnaire
GI tolerance
时间窗: Visit 2 (24 weeks' gestation)
GI tolerance via the GSRS questionnaire
GI tolerance
时间窗: Visit 3 (36 weeks' gestation)
GI tolerance via the GSRS questionnaire
IL-4
时间窗: Visit 1 (baseline, 12 weeks' gestation)
Blood IL-4 levels
IL-4
时间窗: Visit 2 (24 weeks' gestation)
Blood IL-4 levels
次要结局
- IL-1 levels(Visit 3 (36 weeks' gestation))
- hsCRP(Visit 3 (36 weeks' gestation))
- pregnancy complications(Visit 4 (40 days after delivery))
- Vitamin D(Visit 3 (36 weeks' gestation))
- GSH levels(Visit 3 (36 weeks' gestation))
- IgG levels(Visit 3 (36 weeks' gestation))
- TNF-α(Visit 3 (36 weeks' gestation))
- Breastmilk composition(Visit 4 (40 days after delivery))
- Infant birth outcomes(Visit 4 (40 days after delivery))
- infant GI signs and symptoms(Visit 4 (40 days after delivery))
- Adverse events(Visit 4 (40 days after delivery))
- pregnancy complications(Visit 1 (baseline, 12 weeks' gestation))
- pregnancy complications(Visit 2 (24 weeks' gestation))
- pregnancy complications(Visit 3 (36 weeks' gestation))
- GSH levels(Visit 1 (baseline, 12 weeks' gestation))
- GSH levels(Visit 2 (24 weeks' gestation))
- IgG levels(Visit 1 (baseline, 12 weeks' gestation))
- IgG levels(Visit 2 (24 weeks' gestation))
- IL-1 levels(Visit 1 (baseline, 12 weeks' gestation))
- IL-1 levels(Visit 2 (24 weeks' gestation))
- hsCRP(Visit 1 (baseline, 12 weeks' gestation))
- hsCRP(Visit 2 (24 weeks' gestation))
- TNF-α(Visit 1 (baseline, 12 weeks' gestation))
- TNF-α(Visit 2 (24 weeks' gestation))
- Vitamin D(Visit 1 (baseline, 12 weeks' gestation))
- Vitamin D(Visit 2 (24 weeks' gestation))
- Adverse events(Visit 1 (baseline, 12 weeks' gestation))
- Adverse events(Visit 2 (24 weeks' gestation))
- Adverse events(Visit 3 (36 weeks' gestation))
研究者
研究点 (10)
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