Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.

• Conditions: Metabolism; Healthy; Microbiome
• Interventions: Drug: antibiotics

• Registration Number: NCT05738460
• Lead Sponsor: Zhujiang Hospital

Brief Summary

This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1\~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.

Detailed Description

This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0\~1 years old, 1\~2 years old, 2\~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-23
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Infants:37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g,0-3 years of age;
• The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
• The guardian agrees to participate in the study voluntarily.

Exclusion Criteria

• Infants and children with serious congenital abnormalities, infections or clinical diseases;
• Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
• Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
• Any medical or non-medical condition that the investigator deems inappropriate to participate in.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reproductive tract GBS colonization group of mothers during pregnancy	antibiotics	Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics

Primary Outcome Measures

Name	Time	Method
Intestinal flora	Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Secretory IgA	Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Calprotectin	Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.

Secondary Outcome Measures

Name	Time	Method
Intestinal flora	Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Secretory IgA	Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Calprotectin	Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guang Dong, China