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Clinical Trials/NCT03388112
NCT03388112
Unknown
Not Applicable

Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics

Shanghai 10th People's Hospital1 site in 1 country30 target enrollmentFebruary 20, 2017

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(or 21 days) on gut mcrobiome at 42 days
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed Description

This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.

Registry
clinicaltrials.gov
Start Date
February 20, 2017
End Date
December 31, 2018
Last Updated
8 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 infectious diseases treated with antibiotic

Exclusion Criteria

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

Outcomes

Primary Outcomes

change from birth,7 days,14 days(or 21 days) on gut mcrobiome at 42 days

Time Frame: 42 days

change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days)

Secondary Outcomes

  • change from birth on gut mcrobiome at 7 days(7 days)
  • change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)(14 days(or 21days))

Study Sites (1)

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