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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738460
• Other study ID #: CMOH2102
• Status: Active, not recruiting
• Start date: February 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2022
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 37 Weeks to 41 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Metabolism
• Microbiome

Intervention

Drug:
• antibiotics
Reproductive tract GBS colonization group of mothers during pregnancy,Use of antibiotics

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guang Dong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Zhongshan Bo Ai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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