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临床试验/NCT02567071
NCT02567071已完成不适用

Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Diversity of the intestinal microbiota

研究概览

简要总结

The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.

The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • over the age of legal majority
  • delivery by planned C-section at term or vaginal delivery at term
  • registered at a social security service

排除标准

  • HIV or other STD patients
  • immunocompromised patients
  • known streptococcus B carriers
  • known vaginal or perineal herpes infections
  • chronic disease patients (obesity, diabetes, IBD)
  • IMC before pregnancy > 30 kg/m²
  • antibiotic treatments one month before delivery
  • emergency C-section
  • Premature delivery (<37 amenorrhea weeks)
  • hospitalized for more than one week before delivery
  • known HVC infections
  • for the newborns: every diagnosed anomaly
  • patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
  • patients deprived of ther liberty by legal or administrative decisions
  • patients under an exclusion period from another study

研究组 & 干预措施

Placebo Group

Placebo Comparator

75 children born by planned C-section will be exposed to clean swab.

干预措施: clean swab (Other)

Control Group

No Intervention

75 children born vaginally.

Intervention Group

Experimental

75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab.

干预措施: perineal impregnated swab (Other)

结局指标

主要结局

Diversity of the intestinal microbiota

时间窗: 1 year

Intestinal microbiota diversity will be evluated through metagenomics.

次要结局

  • Health status(1 year)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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