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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05086458

Enrollment

Registered

2021-10-21

Start date

2021-08-17

Completion date

2021-10-17

Last updated

2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota

Keywords

gut microbiota, probiotics, infant, cesarean section

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.

Interventions

DIETARY_SUPPLEMENTprobiotics

probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 42 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactRong Yang, MD

yangrongtongji@163.com13321917107

Backup ContactHui Zhong

zhonghuiunique@126.com13701806709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026