Antibiotic-induced Disruption of the Maternal and Infant Microbiota and Adverse Health Outcomes - The ABERRANT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Antibiotic-induced disruption of breast milk microbiota
研究概览
简要总结
The use of antibiotics causes profound changes in the microbiota. However, the magnitude of the effect of intrapartum and early-life antibiotics on the breast milk and the infant oral and intestinal microbiota, and whether effects are only short-term or persist long-term remain uncertain and will be determined in this study.
详细描述
In this prospective cohort study, the investigators will determine the effect of (i) intrapartum antibiotics on the composition of the breast milk, and the infant oral and intestinal microbiota and antibiotic exposure in the first year of life on the composition of the infant intestinal microbiota (including the development and persistence of antibiotic resistance) and (ii) the association of this disruption with adverse health outcomes. (iii) The investigators will also determine the association between the maternal intestinal microbiota, the breast milk microbiota and the infant oral and intestinal microbiota.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy infants
- •term infants (> 37 weeks of gestation)
排除标准
- •maternal HIV infection
- •maternal hepatitis B or C infection
- •antibiotics in the third trimester of pregnancy
- •intake of probiotics during pregnancy
- •infants with the low birth weight <2500 g
- •infants with congenital abnormality
结局指标
主要结局
Antibiotic-induced disruption of breast milk microbiota
时间窗: 2 years
Composition of breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Antibiotic-Induced disruption the infant stool microbiota
时间窗: 2 years
Composition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Maternal to infant microbiota transfer
时间窗: 2 years
Similarities in the composition of the maternal intestinal, the breast milk microbiota and the infant intestinal microbiota, at 38 weeks of pregnancy, at birth and when infants are 7 days, 1, 2, 4 and 6 months of age.
The composition of the intestinal microbiota and adverse health outcomes
时间窗: 2 years
Abundance of certain microbes in the intestinal microbiota and weight (in kg) at 1 and 2 years of age
次要结局
- Antibiotic-Induced disruption the infant stool microbiota(2 years)
- Antibiotic-induced disruption of breast milk microbiota(2 years)
- Introduction of different foods affects the composition of the intestinal microbiota(2 years)
- Administration of oxygen affects the composition of the intestinal microbiota in infants(2 years)
- Administration of antacids affect the composition of the infant intestinal microbiota(2 years)
研究者
Petra Zimmermann
Principal investigator
University of Fribourg