Transfer of Strictly Anaerobe Microbes From Mother to Child

NCT ID: NCT04140747

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-07
• Study Completion Date: 2022-01-31

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.

Conditions

Microbial Colonization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyn Jantscher-Krenn, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Christine Moissl-Eichinger, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

28-524 ex 15/16

Identifier Type: -

Identifier Source: org_study_id