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

Study 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.

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

Conditions
-----------------
Gut Microbiota

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 42 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>the patients in this arm will not receive probiotics. | |
| Experimental: Dietary Supplement<br>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks. | Dietary Supplement: probiotics<br>* probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gut microbiota, probiotics, infant, cesarean section