Trichomonas InfectionNCT07082127
Endosymbionts in Trichomonas Vaginalis Pathogenicity
An observational study of Trichomonas Infection, run by Medical University of Vienna.
Trial summary
With this project, the investigators aim to expand knowledge on the molecular epidemiology of Trichomonas vaginalis, thereby also evaluating the endosymbionts (Mycoplasma hominis and Trichomonas vaginalis virus) and their impact on T. vaginalis virulence. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trichomonas Infection
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients' Centre for Infectious Venereal and Dermatological Diseases: T. vaginalis positive samples (routine control) Austrian Agency for Health and Food Safety: sex-workers
Who may be able to join
- Trichomonas vaginalis positive samples (vaginal swabs/urine) from Outpatients' Centre for Infectious Venereal and Dermatological Diseases
- female sex-workers subjected to routine testing at Austrian Agency for Health and Food Safety
Who cannot join
- samples negative for Trichomonas vaginalis from Outpatients' Centre for Infectious Venereal and Dermatological Diseases
About this study
Official title: The Role of Endosymbionts in Trichomonas Vaginalis Pathogenicity
With this project, the investigators aim to expand knowledge on the molecular epidemiology of Trichomonas vaginalis, thereby also evaluating the endosymbionts (Mycoplasma hominis and Trichomonas vaginalis virus) and their impact on T. vaginalis virulence. A key aspect of the study is the direct comparison between identical T. vaginalis isolates harbouring endosymbionts and those from which the endosymbionts have been removed or inhibited. For this purpose T. vaginalis clinical isolates collected in Outpatients' Centre for Infectious Venereal and Dermatological Diseases, Vienna from patients specimens (vaginal swabs or urine) will be tested. Mycoplasma hominis isolates already collected from patients samples will also be analyzed and compared with M. hominis, which are T. vaginalis endosymbionts.
In addition, 700 samples from female sex workers in Austria, who undergo regular medical check-ups, will be examined. The prevalence of sexually transmitted diseases (STDs) will be evaluated using DNA extracted from vaginal swabs, with a particular focus on parasite Trichomonas vaginalis and bacterium M. hominis. Of particular interest is the study of the prevalence of these organisms in a cohort of women who are at increased risk of infection with these pathogens due to their occupation. Moreover, the study will provide detailed information on possible co-infections, as data from routine screenings are available.
Read the detailed description
For this specific project, patient samples will be cultured in Outpatients' Centre for Infectious Venereal and Dermatological Diseases, Vienna on modified Columbia agar. Specimens will be collected either with a swab, which is then smeared onto the agar plates, or as urine samples, which will be directly spread onto the agar plates. Agar plates that show growth of T. vaginalis after one week of anaerobic incubation at 37°C or M. hominis after two days of anaerobic incubation at 37°C will be set aside. Positive cultures on these agar plates will be collected and transferred to Institute for Specific Prophylaxis and Tropical Medicine (ISPTM) Medical University of Vienna. T. vaginalis and M. hominis isolates will be used for the further characterization. It is planned to remove endosymbionts from the collected T. vaginalis isolates and then test their viability, cytotoxicity, release of pro-inflammatory cytokines and nitric oxide production. M. hominis will be released from T. vaginalis using plasmocin, whereas 2'-C-methylcytidine will be used for Trichomonas vaginalis virus inhibitory assay. The lactase dehydrogenase assay (LDH) will be used to determine cytotoxicity of primary vaginal cells after contact with different T. vaginalis isolates. THP-1 cells (cells derived from leukemia monocytes) will be stimulated with different T. vaginalis isolates and proinflammatory cytokine and nitric oxide production will be evaluated. The expression profiles of putative virulence genes in M. hominis endosymbionts will be also tested. Detection of Ureaplasma spp. DNA in the DNA isolated from T. vaginalis isolates will be performed by PCR and presence confirmed by immunofluorescence and Ureaplasma-specific antibodies.
Vaginal swabs from individual sex-workers (delivered from Austrian Agency for Health and Food Safety) will be used for DNA isolation. For the detection of pathogens, we will use protocols that we have established in our previous studies. Amplified products will be sent for sequencing and compared with reference sequences from GenBank.
- Conditions
- Trichomonas Infection
- Medical subject headings
- Trichomonas Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of T. vaginalis isolates and evaluation of the proportion of sexually transmitted agents in vaginal swabs of Austrian sex workers
Clinical isolates of T. vaginalis or vaginal swabs taken from sex workers will be used in the study.
Researchers will not have access to any patient information. The results of the experiments conducted on samples from sex workers will be evaluated by sequencing the products obtained by PCR (with primers detecting different sexually transmitted pathogens) and comparing them with the Gene Bank data. In addition, the researchers will assess the percentage of samples positive for T. vaginalis, M. hominis, Ureaplasma spp. among a random group of samples obtained from anonymous sex workers.
Clinical isolates of T. vaginalis will be tested by PCR for the presence of endosymbionts (M. hominis, T. vaginalis virus). PCR products will also be sequenced and results will be compared with those present in the Gene Bank.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startOct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonas InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Lesiak-Markowicz, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082127
- Sponsor's protocol ID
- FWF-ID KLP6210324
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endosymbionts in Trichomonas Vaginalis Pathogenicity
- ClinicalTrials.gov ID
- NCT07082127
- Acronym / sponsor ID
- FWF-ID KLP6210324
- Conditions
- Trichomonas Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Jul 2025 (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.
With this project, the investigators aim to expand knowledge on the molecular epidemiology of Trichomonas vaginalis, thereby also evaluating the endosymbionts (Mycoplasma hominis and Trichomonas vaginalis virus) and their impact on T. vaginalis virulence. A key aspect of the study is the direct comparison between identical T. vaginalis isolates harbouring endosymbionts and those from which the endosymbionts have been removed or inhibited. For this purpose T. vaginalis clinical isolates collected in Outpatients' Centre for Infectious Venereal and Dermatological Diseases, Vienna from patients specimens (vaginal swabs or urine) will be tested. Mycoplasma hominis isolates already collected from patients samples will also be analyzed and compared with M. hominis, which are T. vaginalis endosymbionts.
In addition, 700 samples from female sex workers in Austria, who undergo regular medical check-ups, will be examined. The prevalence of sexually transmitted diseases (STDs) will be evaluated using DNA extracted from vaginal swabs, with a particular focus on parasite Trichomonas vaginalis and bacterium M. hominis. Of particular interest is the study of the prevalence of these organisms in a cohort of women who are at increased risk of infection with these pathogens due to their occupation. Moreover, the study will provide detailed information on possible co-infections, as data from routine screenings are available.
Detailed description
For this specific project, patient samples will be cultured in Outpatients' Centre for Infectious Venereal and Dermatological Diseases, Vienna on modified Columbia agar. Specimens will be collected either with a swab, which is then smeared onto the agar plates, or as urine samples, which will be directly spread onto the agar plates. Agar plates that show growth of T. vaginalis after one week of anaerobic incubation at 37°C or M. hominis after two days of anaerobic incubation at 37°C will be set aside. Positive cultures on these agar plates will be collected and transferred to Institute for Specific Prophylaxis and Tropical Medicine (ISPTM) Medical University of Vienna. T. vaginalis and M. hominis isolates will be used for the further characterization. It is planned to remove endosymbionts from the collected T. vaginalis isolates and then test their viability, cytotoxicity, release of pro-inflammatory cytokines and nitric oxide production. M. hominis will be released from T. vaginalis using plasmocin, whereas 2'-C-methylcytidine will be used for Trichomonas vaginalis virus inhibitory assay. The lactase dehydrogenase assay (LDH) will be used to determine cytotoxicity of primary vaginal cells after contact with different T. vaginalis isolates. THP-1 cells (cells derived from leukemia monocytes) will be stimulated with different T. vaginalis isolates and proinflammatory cytokine and nitric oxide production will be evaluated. The expression profiles of putative virulence genes in M. hominis endosymbionts will be also tested. Detection of Ureaplasma spp. DNA in the DNA isolated from T. vaginalis isolates will be performed by PCR and presence confirmed by immunofluorescence and Ureaplasma-specific antibodies.
Vaginal swabs from individual sex-workers (delivered from Austrian Agency for Health and Food Safety) will be used for DNA isolation. For the detection of pathogens, we will use protocols that we have established in our previous studies. Amplified products will be sent for sequencing and compared with reference sequences from GenBank.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients' Centre for Infectious Venereal and Dermatological Diseases: T. vaginalis positive samples (routine control) Austrian Agency for Health and Food Safety: sex-workers
Key inclusion criteria (2 listed)
- Trichomonas vaginalis positive samples (vaginal swabs/urine) from Outpatients' Centre for Infectious Venereal and Dermatological Diseases
- female sex-workers subjected to routine testing at Austrian Agency for Health and Food Safety
Key exclusion criteria (1 listed)
- samples negative for Trichomonas vaginalis from Outpatients' Centre for Infectious Venereal and Dermatological Diseases
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
Characterisation of T. vaginalis isolates and evaluation of the proportion of sexually transmitted agents in vaginal swabs of Austrian sex workers
Time frame: 2 years
Clinical isolates of T. vaginalis or vaginal swabs taken from sex workers will be used in the study. Researchers will not have access to any patient information. The results of the experiments conducted on samples from sex workers will be evaluated by sequencing the products obtained by PCR (with primers detecting different sexually transmitted pathogens) and comparing them with the Gene Bank data. In addition, the researchers will assess the percentage of samples positive for T. vaginalis, M. hominis, Ureaplasma spp. among a random group of samples obtained from anonymous sex workers. Clinical isolates of T. vaginalis will be tested by PCR for the presence of endosymbionts (M. hominis, T. vaginalis virus). PCR products will also be sequenced and results will be compared with those present in the Gene Bank.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Trichomonas Infection, run by Medical University of Vienna.
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 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Characterisation of T. vaginalis isolates and evaluation of the proportion of sexually transmitted agents in vaginal swabs of Austrian sex workers (time frame: 2 years). 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 24 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.