Microbial ColonizationTRAMICNCT04140747
Transfer of Strictly Anaerobe Microbes From Mother to Child
An observational study of Microbial Colonization, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- Type of treatment
- Pill or oral medicine
- How many people
- 94 participants
- Where
- 1 siteAustria
- Study dates
- 7 Oct 2016to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- healthy women
- pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- 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.
- Conditions
- Microbial Colonization
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
maternal microbiome
difference between non-pregnant and pregnant women
Measured: 2020-2023
fetal/neonatal microbiome
difference between vaginal and C-section born infants
Measured: 2020-2023
Secondary outcomes (1)
Human milk oligosaccharides
associations of HMOs with maternal/infant microbiome
Measured: 2020-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start7 Oct 2016
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyn Jantscher-Krenn, PhD, Principal investigator, Medical University of GrazChristine Moissl-Eichinger, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140747
- Sponsor's protocol ID
- 28-524 ex 15/16
- Acronym
- TRAMIC
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Strictly Anaerobe Microbes From Mother to Child - a Pilot Study
- ClinicalTrials.gov ID
- NCT04140747
- Acronym / sponsor ID
- TRAMIC / 28-524 ex 15/16
- Conditions
- Microbial Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- healthy women
- pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital
Key exclusion criteria (8 listed)
- bacterial/ fungal infections
- use of antibiotics/ probiotics in past 3 months
- fetal anomalies
- multiple pregnancies
- diabetes type 1, 2, gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maternal microbiome
Time frame: 2020-2023
difference between non-pregnant and pregnant women
fetal/neonatal microbiome
Time frame: 2020-2023
difference between vaginal and C-section born infants
1 secondary outcome
Human milk oligosaccharides
Time frame: 2020-2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Jantscher-Krenn, PhD principal investigator
Medical University of Graz
Christine Moissl-Eichinger, PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal microbiome (time frame: 2020-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.