Transfer of Strictly Anaerobe Microbes From Mother to Child

Completed

• Conditions: Microbial Colonization

• Registration Number: NCT04140747
• Lead Sponsor: Medical University of Graz

Brief Summary

This study aims to investigate the changes in the microbiota at different body sites in late pregnancy, in comparison with non-pregnant women, with particular emphasis on archaea, and to identify possible maternal-to-child transfer routes for acquisition of strictly anaerobic microorganisms by analyzing the gut microbiota of new born infants (delivered vaginally or by C-section).

Detailed Description

The investigators hypothesize that changes occur in the microbial community during pregnancy in different body sites (vagina, oral etc.) and that the main source of these microorganisms is the mother for vaginally born infants, while C-section born infants acquire most of the anaerobic microbial communities from other sources rather than mother's vaginal and gut microbiota, such as the environment.

Specific Research Objectives will be:

1. To investigate diversity of archaea in the vagina of healthy women in the context with community state types (CSTs), and compare vaginal microbiome in pregnant with non-pregnant healthy women.

2. To identify the presence of archaea in different body sites (oral, gut) or body fluids (amniotic fluid, urine, human milk) within the perinatal microbial communities.

3. To investigate the presence of archaea in the infant's first-days-of-life intestinal community, and to identify the sources of these microorganisms by using source tracking approach.

4. To investigate Human Milk Oligosaccharides (HMOs) in maternal (serum, saliva, urine, breast milk) or intrauterine sources (amniotic fluid) as potential modifiers of the microbial communities in these sites.

5. To analyze associations of maternal/ intrauterine HMOs with infant HMOs and microbiota (meconium and infant stool) in order to investigate vertical transmission of microbiota to the infant.

Study Timeline

• Study Start: 2016-10-07
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• healthy women
• pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital

Exclusion Criteria

• bacterial/ fungal infections
• use of antibiotics/ probiotics in past 3 months
• fetal anomalies
• multiple pregnancies
• diabetes type 1, 2, gestational diabetes
• hypertension, preeclampsia/HELLP
• HIV ( human immunodeficiency virus), HCV (Hepatitis C)
• drug abuse, smoking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal/neonatal microbiome	2020-2023	difference between vaginal and C-section born infants
maternal microbiome	2020-2023	difference between non-pregnant and pregnant women

Secondary Outcome Measures

Name	Time	Method
Human milk oligosaccharides	2020-2023	associations of HMOs with maternal/infant microbiome

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria