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

NCT05738460 | Unknown

• 1 other identifier: CMOH2102
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Metabolism; Microbiome

Keywords

Microbiome,; maternal and offspring; healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Intestinal flora

  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

  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

  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 Outcomes (3)

• Intestinal flora

  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

  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

  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

Study Arms (2)

Reproductive tract GBS colonization group of mothers during pregnancy

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

Drug: antibiotics

No reproductive tract GBS colonization group in mothers during pregnancy

No reproductive tract GBS colonization group in mothers during pregnancy

Interventions

antibiotics DRUG

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

Also known as: antibiotic

Reproductive tract GBS colonization group of mothers during pregnancy

Eligibility Criteria

• Age: 37 Weeks - 41 Weeks
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Zhongshan Bo Ai Hospital: collaborator

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Qian Wang

  Southern Medical University, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 22, 2023
• Study Start: February 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 22, 2023

Record last verified: 2022-02

Locations

CN (1)