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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05738460
Enrollment
180
Registered
2023-02-22
Start date
2022-02-23
Completion date
2023-06-30
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Metabolism, Microbiome

Keywords

Microbiome,, maternal and offspring, healthy

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.

Interventions

DRUGantibiotics

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

Sponsors

Zhongshan Bo Ai Hospital
CollaboratorOTHER
Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 41 Weeks

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.

Design outcomes

Primary

MeasureTime frameDescription
CalprotectinFecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Intestinal floraFecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Secretory IgAFecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.

Secondary

MeasureTime frameDescription
Secretory IgAFecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Intestinal floraFecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
CalprotectinFecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.

Other

MeasureTime frameDescription
Intestinal floraFecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
CalprotectinFecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Secretory IgAFecal samples of infants and young children in the observation group and control group at different time points 2~3 years old of offspring were collectedAnalyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026