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Completed

NCT Number: NCT04140747

Transfer of Strictly Anaerobe Microbes From Mother to Child

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical University of Graz

Graz, 8043, Austria

About this study

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:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. maternal microbiome

    Time frame: 2020-2023

    difference between non-pregnant and pregnant women

  2. fetal/neonatal microbiome

    Time frame: 2020-2023

    difference between vaginal and C-section born infants

Secondary outcomes

  1. Human milk oligosaccharides

    Time frame: 2020-2023

    associations of HMOs with maternal/infant microbiome

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: TRAMIC

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2019
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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