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

October 20, 2021 updated by: Huanlong Qin, Shanghai 10th People's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

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.
Time Frame: 42 days
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.
Time Frame: 14 days
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.
Time Frame: birth
Study the microbiota change of stool samples at birth between no intervention group and experimental group.
birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Huanlong Qin, MD, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2021

Primary Completion (Anticipated)

October 17, 2021

Study Completion (Anticipated)

October 17, 2021

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHSYEK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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