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

Not Applicable

• Conditions: Gut Microbiota
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT05086458
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-08-18
• Status Verified: 2021-10
• Primary Completion: 2021-10-17
• Study Completion: 2021-10-17
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Supplement	probiotics	the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change in gut microbiota at 14 days between no intervention and experimental group.	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.	42 days	Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.

Secondary Outcome Measures

Name	Time	Method
Change in gut microbiota at birth between no intervention and experimental group.	birth	Study the microbiota change of stool samples at birth between no intervention group and experimental group.

Trial Locations

Locations (1)

Rong Yang; 🇨🇳 Shanghai, China