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

Z

Zhujiang Hospital

Status

Unknown

Conditions

Metabolism
Healthy
Microbiome

Treatments

Drug: antibiotics

Study type

Observational

Funder types

Other

Identifiers

NCT05738460
CMOH2102

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

37 to 41 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

180 participants in 2 patient groups

Reproductive tract GBS colonization group of mothers during pregnancy
Description:
Reproductive tract GBS colonization group of mothers during pregnancy,Use of antibiotics
Treatment:
Drug: antibiotics
No reproductive tract GBS colonization group in mothers during pregnancy
Description:
No reproductive tract GBS colonization group in mothers during pregnancy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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