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

NCT ID: NCT05086458

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2021-10-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Gut Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No intervention

the patients in this arm will not receive probiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Dietary Supplement

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

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis

Interventions

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probiotics

probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

42 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huanlong Qin, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Rong Yang

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Yang, MD

Role: CONTACT

13321917107

Hui Zhong

Role: CONTACT

13701806709

Facility Contacts

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Rong Yang, MD

Role: primary

13321917107

References

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Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.

Reference Type DERIVED
PMID: 37712964 (View on PubMed)

Other Identifiers

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SHSYEK-001

Identifier Type: -

Identifier Source: org_study_id