Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.

Microbiome, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738473
• Other study ID #: CMOH2101
• Status: Active, not recruiting
• Start date: February 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In view of the current status of prevention and research on GBS disease in mothers and infants at home and abroad, this project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

Description:

This project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 492
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women are 18 to 40 years;
• 35 to 41 weeks of pregnancy;
• Singleton pregnancy;
• Plan for vaginal delivery and postpartum care in the research hospital;
• Pregnant women who volunteered to participate in the study.

Exclusion Criteria:

• Have infectious diseases, serious infections and clinical diseases;
• Use of antibiotics in the past 2 weeks;
• Long-term use of drugs due to digestion, immunity, blood, chronic diseases;
• Sexual behavior, vaginal douching and topical medication within 24 hours before sampling;
• Any medical or non-medical condition that the investigator considers inappropriate to participate.

Related Conditions & MeSH terms

• Microbiome, Human

Intervention

Drug:
• antibiotic
For pregnant women with GBS colonization, antibiotics are used to prevent infection

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
Primary	Intestinal flora	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.	The offspring are born on the 3rd day after birth
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.	The offspring are born on the 3rd day after birth
Primary	Calprotectin	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.	The offspring are born on the 3rd day after birth
Primary	Intestinal flora	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.	The offspring are born on the 42nd day after birth
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.	The offspring are born on the 42nd day after birth
Primary	Calprotectin	Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.	The offspring are born on the 42nd day after birth
Secondary	The effect of IAP to prevent GBS-EOD.	Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome.	Vaginal flora on days 3rd after delivery.
Secondary	The characteristics of vaginal microbiome of pregnant women.	Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS).	Vaginal flora on days 3rd after delivery.
Secondary	The effect of IAP to prevent GBS-EOD.	Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome.	Vaginal flora on days 42nd after delivery.
Secondary	The characteristics of vaginal microbiome of pregnant women.	Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS).	Vaginal flora on days 42nd after delivery.