Viewing Study NCT05738460


Ignite Creation Date: 2025-12-25 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
Study NCT ID: NCT05738460
Status: UNKNOWN
Last Update Posted: 2023-02-22
First Post: 2023-01-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.
Sponsor: Zhujiang Hospital
Organization:

Study Overview

Official Title: The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring
Status: UNKNOWN
Status Verified Date: 2022-02
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: