Origin of the Neonatal Gut Microbiota and Probiotic Intervention

NCT06241222 | Completed

• 1 other identifier: [2019]no.11EthicsCommittee
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 16S rRNA amplicon sequencing of the V4 region

  Difference analysis of each group was performed. All the measurement data are presented as the mean ± standard error. Assessments of Operational Taxonomic Units differences in the probiotic group and control group were performed using independent sample t tests, and P \< 0.05 was considered to indicate statistical significance. Other outcomes were analyzed using multiple linear regression. All data were analyzed using SPSS 23.0 statistical software (SPSS, Inc., Chicago, IL, USA).

  12 months

Study Arms (2)

control group

NO INTERVENTION

pregnancies in control group need no intervention.

probiotics group

EXPERIMENTAL

pregnancies in probiotics group need probiotics management

Drug: Probiotic Blend Oral Tablet

Interventions

Probiotic Blend Oral Tablet DRUG

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

probiotics group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Pregnant inclusive criteria were: 1. Chinese woman who is pregnant with a single fetus; 2. First pregnancy and term delivery. Newborns' inclusive criteria were: 1. Normal weight (\>2500 g, \<4000 g); 2. Term Infant (\>37 weeks, \<42 weeks). 3. Natural birth. Pregnancy exclusive criteria were: 1. Gastrointestinal disease or family history; 2. Vaginitis before pregnancy; 3. Antibiotic usage during pregnancy; 4. Hypertension, Diabetes Mellitus, Hyperthyroidism, Hypothyroidism, Autoimmune Disease, or Other Endocrine and Metabolic Disease; 5. Gestational Hypertensive Disease, Gestational Diabetes Mellitus or Other Gestational Disease; 6. Transfusion History, Organ Transplantation History or Immunotherapy History. Newborn's exclusive criteria were: 1. Abnormal weight (\>4000 g, \<2500 g); 2. With Congenital Diseases;3. Intrapartum Fetal Complication.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Zhe Li

Guangzhou, Guangdong, 510000, China

Location

Related Publications (5)

• Chen Y, Li Z, Tye KD, Luo H, Tang X, Liao Y, Wang D, Zhou J, Yang P, Li Y, Su Y, Xiao X. Probiotic Supplementation During Human Pregnancy Affects the Gut Microbiota and Immune Status. Front Cell Infect Microbiol. 2019 Jul 16;9:254. doi: 10.3389/fcimb.2019.00254. eCollection 2019.

  PMID: 31380297 BACKGROUND

• Yang P, Li Z, Tye KD, Chen Y, Lu T, He Z, Zhou J, Xiao X. Effects of an orally supplemented probiotic on the autophagy protein LC3 and Beclin1 in placentas undergoing spontaneous delivery during normal pregnancy. BMC Pregnancy Childbirth. 2020 Apr 15;20(1):216. doi: 10.1186/s12884-020-02905-z.

  PMID: 32295534 BACKGROUND

• Huang T, Li Z, Tye KD, Chan SN, Tang X, Luo H, Wang D, Zhou J, Duan X, Xiao X. Probiotic supplementation during pregnancy alters gut microbial networks of pregnant women and infants. Front Microbiol. 2022 Dec 1;13:1042846. doi: 10.3389/fmicb.2022.1042846. eCollection 2022.

  PMID: 36532501 BACKGROUND

• Meng L, Fan G, Xie H, Tye KD, Xia L, Luo H, Tang X, Huang T, Lin J, Ma G, Xiao X, Li Z. Maternal-to-neonatal microbial transmission and impact of prenatal probiotics on neonatal gut development. J Transl Med. 2025 Oct 30;23(1):1198. doi: 10.1186/s12967-025-07293-6.

  PMID: 41168767 DERIVED

• Ma G, Li Y, Tye KD, Huang T, Tang X, Luo H, Wang D, Zhou J, Li Z, Xiao X. The effect of oral probiotics in the last trimester on the human milk and infant gut microbiotas at six months postpartum: A randomized controlled trial. Heliyon. 2024 Aug 30;10(17):e37157. doi: 10.1016/j.heliyon.2024.e37157. eCollection 2024 Sep 15.

  PMID: 39286230 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 9, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)