Transfer of Strictly Anaerobe Microbes From Mother to Child (TRAMIC)

Transfer of Strictly Anaerobe Microbes From Mother to Child - a Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: Microbial Colonization

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8043
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy non-pregnant women and women with an ongoing healthy pregnancy. 3 groups will be formed: non-pregnant women (n=30), women delivering vaginally (n=30) and women undergoing C-section (n=30).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
non-pregnant women; Samples will be collected from 30 healthy, non-pregnant women in the reproductive age: blood, urine, stool, saliva, oral swabs, vaginal swabs
pregnant women delivering vaginally; From 30 healthy, pregnant women giving vaginal birth, samples will be collected shortly before, during and after birth from maternal and newborn sites: maternal blood, urine, stool, saliva, oral swabs, vaginal swabs; cord blood, colostrum, meconium, infant oral swabs
pregnant women undergoing C-section; From 30 healthy, pregnant women giving vaginal birth, samples will be collected shortly before, during and after birth from maternal and newborn sites: maternal blood, urine, stool, saliva, oral swabs, vaginal swabs; amniotic fluid, cord blood, colostrum, meconium, infant oral swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal microbiome	difference between non-pregnant and pregnant women	2020-2023
fetal/neonatal microbiome	difference between vaginal and C-section born infants	2020-2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human milk oligosaccharides	associations of HMOs with maternal/infant microbiome	2020-2023

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Evelyn Jantscher-Krenn, PhD, Medical University of Graz; Principal Investigator: Christine Moissl-Eichinger, PhD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2016
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 28-524 ex 15/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No