Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
研究概览
简要总结
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.
详细描述
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-eventful pregnancy
- •planned elective CS
- •Finnish language competency
排除标准
- •maternal refusal
- •positive findings in screening samples
- •maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord)
- •travel outside European Union during 3 months prior to delivery
- •CS after the onset of labor (non-elective CS)
- •birth below 37 weeks of gestation
- •Apgar score of less than 8
- •disturbances of neonatal adaptation (such as transient tachypnea of the newborn)
- •antibiotic treatment of the newborn before discharge
结局指标
主要结局
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
时间窗: At three months of age
Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age
次要结局
- Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing(At 6, 12 and 24 months of age)
- Difference in markers of aeroallergen immunoglobulin Es(At 24 months of age)
- Difference in markers of cow milk immunoglobulin Es(At 12 months of age)
- Difference in tetanus and measles, mumps and rubella vaccine responses(At 12 and 24 months of age)
研究者
Otto Helve
Adjunct professor
Helsinki University Central Hospital