Origin of the Neonatal Gut Microbiota and Probiotic Intervention

Microbiota Clinical Trial

Official title:

Origin of the Neonatal Gut Microbiota and Probiotic Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06241222
• Other study ID #: [2019]no.11EthicsCommittee
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2024
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to evaluate the origin of the neonatal gut microbiota in 14th days and Probiotic intervention. Samples were obtained from a total of 30 pregnant individuals and their offspring, divided into control group and porbiotics group, analyzing by 16S rRNA amplicon sequencing of the V4 region to evaluate the composition of them. Multiple linear regression were used to evaluate the origin of neonatal gut microbiota.

Description:

Study design and participants A total of 30 samples were obtained from pregnant individuals receiving antenatal care at the 1st Affiliated Hospital of Jinan University. Informed consent was obtained from pregnant women (at least 32 gestational weeks) who met the inclusion criteria. Newborns were followed until 14 days after natural delivery. 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. Pregnanct 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.

Probiotic management 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, and those in the control group took no pills.

Fecal, vaginal secretion, placental, and meconium collection Fecal collection Feces from pregnant patients were collected twice-between weeks 32 and 34 and before natural labor. Feces collected at weeks 32-34 were collected internally, thereby avoiding contamination with foreign material. The feces were stored in a domestic refrigerator and transferred to the laboratory freezer at -80 ºC for 24 hours. Feces collected before labor were obtained in the hospital and transferred to the laboratory freezer within 30 min of collection.

Vaginal secretion collection Vaginal secretions were collected twice between weeks 32 and 34 and before natural labor. The pregnant woman was asked to not engage in sexual behavior, clean the vulva, clean the vagina, or use vaginal medicine within 48 hours before sample collection. Vaginal secretions before natural labor were collected before membrane rupture occurred. The samples were transferred to the laboratory freezer within 30 min of collection, thereby avoiding contamination by foreign material.

Placenta collection Placenta samples ranging from the entire umbilical cord to 3 cm were collected by stripping the amniotic membrane after natural birth. The blood was rinsed with sterile saline. Four to six pieces of placenta were sampled from the fetal surface. Each piece had a volume of approximately 1 cm3. The placenta sample was transferred to the laboratory freezer within 30 min of collection.

Meconium collection Meconium was collected three times on the 1st day, the 3rd day, and the 14th day after natural delivery On the 1st day and 3rd day, meconium was collected internally, thereby avoiding contamination with foreign material in the hospital, and was transferred to the laboratory freezer within 30 min of collection. On the 14th day, meconium was collected, stored in a domestic refrigerator, and then transferred to a laboratory freezer within 24 hours of collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microbiota

Intervention

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

Locations

Country	Name	City	State
China	Zhe Li	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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