CClinicalTrials.gg
Status unknownNCT05086458Updated Oct 21, 2021

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

An interventional study of probiotics in Gut Microbiota, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 1 Hour to 42 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Hour to 42 Days
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gut Microbiota

Keywords

  • gut microbiota
  • probiotics
  • infant
  • cesarean section
03

In context

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 42 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Neonates born by caesarean section

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementprobiotics

    probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 42 days

  2. 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.

    Time frame: 14 days

Secondary outcomes

  1. 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.

    Time frame: birth

07

Study locations

1 of 1 sites recruiting
  • Rong Yang
    Shanghai, 20072, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05086458
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Huanlong Qin (Director, Shanghai 10th People's Hospital) — Principal investigator
First posted
Oct 21, 2021
Start date
Aug 17, 2021
Primary completion
Oct 17, 2021 (estimated)
Completion
Oct 17, 2021 (estimated)
Last update
Oct 21, 2021

Study contacts

Rong Yang, MD
Contact
yangrongtongji@163.com
13321917107
Hui Zhong
Contact
zhonghuiunique@126.com
13701806709
Huanlong Qin, MD
principal investigator · Shanghai 10th People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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