Vaginal MicrobiomeIsalaNCT04319536
Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
An observational study of Vaginal Microbiome and Skin Microbiome, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome, Skin Microbiome, Saliva Microbiome
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2020to Jul 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study populations involves healthy women from 18 years and older.
Who may be able to join
- none
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp and University Hospital Antwerp
Antwerp, 2020
Sarah Lebeer, Professor, +32 3 265 32 85, sarah.lebeer@uantwerpen.be
Sarah Ahannach, +32 3 265 32 17, sarah.ahannach@uantwerpen.be
About this study
The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy microbiome. Therefore, microbial DNA from swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the microbial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics).
- Conditions
- Vaginal Microbiome, Skin Microbiome, Saliva Microbiome
- Being tested
- no intervention
- Keywords
- Metagenomic sequencing, vaginal microbiome, skin microbiome, saliva microbiome, large-scale self-sampling cohort, Microbiota, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
self-sampling
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq
After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyse taxonomic and functional data. The investigators will specifically screen for health-promoting and pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (i.e. beneficial microbes such as lactic acid bacteria).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Mar 2020
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ethisch.comite@uza.be, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319536
- Sponsor's protocol ID
- B300201942076
- Acronym
- Isala
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Eekert N, Biegel N, De Kort L, Verhoeven V, Gehrmann T, Masquillier C, Ahannach S, Lebeer S. Relationship between classic indicators of health behaviour and contraceptive choices in women in Flanders. BMC Womens Health. 2024 May 5;24(1):275. doi: 10.1186/s12905-024-03079-y.
PubMed 38706007
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
- ClinicalTrials.gov ID
- NCT04319536
- Acronym / sponsor ID
- Isala / B300201942076
- Conditions
- Vaginal Microbiome, Skin Microbiome, Saliva Microbiome
- Keywords
- Metagenomic sequencing, vaginal microbiome, skin microbiome, saliva microbiome, large-scale self-sampling cohort, Microbiota, Probiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Mar 2020 (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.
The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy microbiome. Therefore, microbial DNA from swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the microbial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations involves healthy women from 18 years and older.
Key inclusion criteria (1 listed)
- none
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionself-sampling | Other | Healthy individuals |
Primary outcome
Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq
Time frame: up to 5 years
After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyse taxonomic and functional data. The investigators will specifically screen for health-promoting and pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (i.e. beneficial microbes such as lactic acid bacteria).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 38706007Van Eekert N, Biegel N, De Kort L, Verhoeven V, Gehrmann T, Masquillier C, Ahannach S, Lebeer S. Relationship between classic indicators of health behaviour and contraceptive choices in women in Flanders. BMC Womens Health. 2024 May 5;24(1):275. doi: 10.1186/s12905-024-03079-y.
Related trials for Vaginal Microbiome
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
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.
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 Vaginal Microbiome and Skin Microbiome, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Lebeer, Professor (+32 3 265 32 85, sarah.lebeer@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319536, which also lists 1 linked publication.
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 Jan 2021.