Clinical trial

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

Name

CMOH2102

Description

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.

Trial arms

Trial start

2022-02-23

Estimated PCD

2023-06-30

Trial end

2023-06-30

Treatment

antibiotics

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

Arms:

Reproductive tract GBS colonization group of mothers during pregnancy

Other names:

antibiotic

Size

180

Primary endpoint

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

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

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

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

Updated at

2023-02-22

1 organization

1 drug

3 indications

Organization

Drug

Indication

Indication

Indication