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Clinical Trials/NCT05086458
NCT05086458
Unknown
Not Applicable

Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study

Shanghai 10th People's Hospital1 site in 1 country30 target enrollmentAugust 17, 2021
ConditionsGut Microbiota

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Microbiota
Sponsor
Shanghai 10th People's Hospital
Enrollment
30
Locations
1
Primary Endpoint
Change in gut microbiota at 14 days between no intervention and experimental group.
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.

Detailed Description

This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,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 born by cesarean section.

Registry
clinicaltrials.gov
Start Date
August 17, 2021
End Date
October 17, 2021
Last Updated
4 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

  • Neonates born by caesarean section

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 With infectious diseases

Outcomes

Primary Outcomes

Change in gut microbiota at 14 days between no intervention and experimental group.

Time Frame: 14 days

Study the microbiota change of stool samples 14 days between no intervention group and experimental group.

Change in gut microbiota at 42 days between no intervention group and experimental group.

Time Frame: 42 days

Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.

Secondary Outcomes

  • Change in gut microbiota at birth between no intervention and experimental group.(birth)

Study Sites (1)

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