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临床试验/NCT03510936
NCT03510936Unknown不适用

Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA

研究概览

简要总结

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

详细描述

This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

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
Single (Participant)

入排标准

年龄范围
1 Hour 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns with jaundice treated with blue light phototherapy

排除标准

  • Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases

研究组 & 干预措施

blue light phototherapy

No Intervention

the patients in this arm will not receive probiotics.

probiotics concurrent with phototherapy

Experimental

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks

干预措施: Probiotics (Dietary Supplement)

结局指标

主要结局

change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA

时间窗: 42 days

change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days

次要结局

  • change from birth on gut microbiome at 7 days by 16S rRNA(7 days)
  • change from birth and 7 days on gut microbiome at 14 days by 16S rRNA(14 days)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huanlong Qin

Director

Shanghai 10th People's Hospital

研究点 (1)

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