Endosymbionts in Trichomonas Vaginalis Pathogenicity

NCT07082127 | Not Yet Recruiting

• 1 other identifier: FWF-ID KLP6210324
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Trichomonas Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• samples negative for Trichomonas vaginalis from Outpatients' Centre for Infectious Venereal and Dermatological Diseases

Sponsors & Collaborators

• Medical University of Vienna: lead

Biospecimen

Retention: SAMPLES WITH DNA

vaginal swabs

MeSH Terms

Conditions

Trichomonas Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share