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Origin of the Neonatal Gut Microbiota and Probiotic Intervention

NCT06241222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-09

No results posted yet for this study

Summary

This study aim to evaluate the composition and origin of the neonatal gut microbiota after birth and Probiotic intervention. Samples were obtained from a total of 30 pregnant individuals and their offspring, divided into control group and porbiotics group. Postpartum human milk and infant fecal specimens were collected for a period of 6 months. The samples were analyzed using 16S rRNA amplicon sequencing of the V3-V4 region to evaluate the microbial composition. The Shannon index, Simpson index and nonmetric multidimensional scaling were used to evaluate the diversity of the microbiota, while the co-occurrence network and LEfSe were used to evaluate the characteristics of the microbiota of pregnancies and their infants in each groups.

Conditions

  • Microbiota

Interventions

DRUG

Probiotic Blend Oral Tablet

In our study, fourteen pregnant women were randomly assigned to the probiotic group, and the rest were assigned to the control group. After enrollment, pregnant women in the probiotic group received a combination of living Bifidobacterium longum (5 ∗ 106 CFU), Lactobacillus delbrueckii bulgaricus (5 ∗ 105 CFU) and Streptococcus thermophilus (5 ∗ 105 CFU) tablets produced by Neimengu Shuangqi Pharmaceutical Co., Ltd. Pregnant individuals in the probiotic group were administered two tablets twice a day (2 g/d) until natural delivery

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06241222 on ClinicalTrials.gov