Clinical trial NCT05738460: Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.
Official title: The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Metabolism
Microbiome
Keywords: Microbiome,
maternal and offspring
healthy
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan Bo Ai Hospital
First posted: 2023-02-22
Enrollment: 180
Sex: ALL
Minimum age (years): 37
Maximum age (years): 41
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Intestinal flora
timeFrame: 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
measure: Secretory IgA
timeFrame: 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
measure: Calprotectin
timeFrame: 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:
measure: Intestinal flora
timeFrame: 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
measure: Secretory IgA
timeFrame: 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
measure: Calprotectin
timeFrame: 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:
measure: Intestinal flora
timeFrame: 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
measure: Secretory IgA
timeFrame: 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
measure: Calprotectin
timeFrame: 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
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guang Dong
Study officials:
affiliation: Southern Medical University, China
name: Qian Wang
role: STUDY_CHAIR
References: