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

The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Microbiome; Metabolism
• Intervention / Treatment: Drug: antibiotics

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510000
      • Zhujiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants: 37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g, 0-3 years of age; 2. The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 - 41 weeks to complete the GBS screening; 3. The guardian agrees to participate in the study voluntarily.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reproductive tract GBS colonization group of mothers during pregnancy; Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics	Drug: antibiotics; Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics; Other Names: antibiotic
No reproductive tract GBS colonization group in mothers during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal flora	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.	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
Secretory IgA	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.	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
Calprotectin	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal flora	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.	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
Secretory IgA	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.	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
Calprotectin	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal flora	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.	Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected
Secretory IgA	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.	Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected
Calprotectin	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.	Fecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collected

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Zhongshan Bo Ai Hospital
• Investigators: Study Chair: Qian Wang, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: healthy; Microbiome,; maternal and offspring
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: CMOH2102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No