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NCT05086458 Clinical Trial

Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants

Gut Microbiota Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05086458
Other study ID # SHSYEK-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2021
Est. completion date October 17, 2021

Study information
Verified date October 2021
Source Shanghai 10th People's Hospital
Contact Rong Yang, MD
Phone 13321917107
Email yangrongtongji@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date October 17, 2021
Est. primary completion date October 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 42 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• probiotics
probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis

Locations
Country Name City State
China Rong Yang Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in gut microbiota at 42 days between no intervention group and experimental group. Study the microbiota change of stool samples at 42 days between no intervention group and experimental group. 42 days
Primary Change in gut microbiota at 14 days between no intervention and experimental group. Study the microbiota change of stool samples 14 days between no intervention group and experimental group. 14 days
Secondary Change in gut microbiota at birth between no intervention and experimental group. Study the microbiota change of stool samples at birth between no intervention group and experimental group. birth
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