Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedOctober 21, 2021
October 1, 2021
2 months
August 18, 2021
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in gut microbiota at birth between no intervention and experimental group.
birth
Study Arms (2)
No intervention
NO INTERVENTIONthe patients in this arm will not receive probiotics.
Dietary Supplement
EXPERIMENTALthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks.
Interventions
probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis
Eligibility Criteria
You may qualify if:
- Neonates born by caesarean section
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rong Yang
Shanghai, 20072, China
Related Publications (1)
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.
PMID: 37712964DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huanlong Qin, MD
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 18, 2021
First Posted
October 21, 2021
Study Start
August 17, 2021
Primary Completion
October 17, 2021
Study Completion
October 17, 2021
Last Updated
October 21, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share