Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- BMI at 24 months of age
研究概览
简要总结
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
排除标准
- •Chorioamnionitis
- •Pre-eclampsia and hepatogestosis
- •Suspected malformation or serious condition of the foetus and neonates
- •Serious infection or other conditions not permitting breast milk feeding
研究组 & 干预措施
Synbiotic
Bifidobacterium bifidum and human milk oligosaccharides (HMOs)
干预措施: Synbiotic Supplement (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
BMI at 24 months of age
时间窗: From enrollment to 24 months of age
Child's body mass index (BMI) at the age of 24 months
次要结局
- Mother's microbiome(From enrollment to 6 months after giving birth)
- Respiratory tract infections(From enrollment to 24 months of age)
- Height(From enrollment to 24 months of age)
- Breast milk microbiome(From enrollment to 6 months of age)
- Weight(From enrollment to 24 months of age)
- Growth velocity(From enrollment to 3 months of age)
- Inflammatory markers(From enrollment to 6 months of age)
- Child's microbiome(From enrollment to 24 months of age)
- Hormonal levels(From enrollment to 6 months of age)
研究者
Erika Isolauri
Professor of Paediatrics
Turku University Hospital