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Clinical Trials/NCT03510936
NCT03510936
Unknown
Not Applicable

Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

Shanghai 10th People's Hospital1 site in 1 country30 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Microbiome
Sponsor
Shanghai 10th People's Hospital
Enrollment
30
Locations
1
Primary Endpoint
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Huanlong Qin

Director

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Newborns with jaundice treated with blue light phototherapy

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 42 days

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

Secondary Outcomes

  • 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)

Study Sites (1)

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