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Transfer of Strictly Anaerobe Microbes From Mother to Child

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04140747
Acronym
TRAMIC
Enrollment
94
Registered
2019-10-28
Start date
2016-10-07
Completion date
2022-01-31
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
maternal microbiome2020-2023difference between non-pregnant and pregnant women
fetal/neonatal microbiome2020-2023difference between vaginal and C-section born infants

Secondary

MeasureTime frameDescription
Human milk oligosaccharides2020-2023associations of HMOs with maternal/infant microbiome

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026