Transfer of Strictly Anaerobe Microbes From Mother to Child

Microbial Colonization Clinical Trial

— TRAMIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140747
• Other study ID #: 28-524 ex 15/16
• Status: Recruiting
• Start date: October 7, 2016
• Est. completion date: October 2023

Study information

• Verified date: September 2021
• Source: Medical University of Graz
• Contact: Evelyn Jantscher-Krenn, PhD
• Phone: +43 385 316
• Email: evelyn.jantscher-krenn[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal microbiome	difference between non-pregnant and pregnant women	2020-2023
Primary	fetal/neonatal microbiome	difference between vaginal and C-section born infants	2020-2023
Secondary	Human milk oligosaccharides	associations of HMOs with maternal/infant microbiome	2020-2023