CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Probiotic Blend Oral Tabletdrug
Likely dose
Probiotic Blend Oral Tablet 2 gfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06241222
NCT06241222N/ACompleted

Origin of the Neonatal Gut Microbiota and Probiotic Intervention

Third Affiliated Hospital, Sun Yat-Sen University·interventional·Posted Feb 5, 2024·Updated Sep 9, 2025

In Brief

A clinical study evaluating Probiotic Blend Oral Tablet for Microbiota. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMicrobiota
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 5, 2024
Enrollment StartJan 1, 2018
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 2.4 years ago

Interventions

Probiotic Blend Oral Tabletdrug

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