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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-23

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Metabolism Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Reproductive tract GBS colonization group of mothers during pregnancy

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

antibiotics

Intervention Type DRUG

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

No reproductive tract GBS colonization group in mothers during pregnancy

No interventions assigned to this group

Interventions

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antibiotics

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

Intervention Type DRUG

Other Intervention Names

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antibiotic

Eligibility Criteria

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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.

Minimum Eligible Age

37 Weeks

Maximum Eligible Age

41 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No