Cytolytic Vaginosis Multicentre Registry

May 6, 2024 updated by: University of Alberta

The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:

  • What are risk factors of cytolytic vaginosis?
  • Are there defining symptoms of cytolytic vaginosis?
  • What features on wet mount should be used to diagnosis cytolytic vaginosis?
  • Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?
  • Do characteristics of cytolytic vaginosis vary between sites/countries?

Study Overview

Status

Recruiting

Conditions

Detailed Description

Cytolytic vaginosis is a largely unknown, debated, and equivocal vaginal condition. It is unclear whether cytolytic vaginosis is a variant of normal vaginal microbiome or should be considered a vaginal dysbiosis condition, similar to bacterial vaginosis. This multicentre registry will enroll women that have signs/symptoms consistent with cytolytic vaginosis to better characterize it.

Women at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio De Janeiro
      • Niterói, Rio De Janeiro, Brazil
        • Not yet recruiting
        • Universidade Federal Fluminense-UFF
        • Principal Investigator:
          • Isabel do Val, Dr.
        • Sub-Investigator:
          • Susana Aidé, Dr.
        • Sub-Investigator:
          • Caroline Oliveira, Dr.
  • Canada
    • Alberta
      • Multiple Locations, Alberta, Canada
        • Recruiting
        • Outpatient clinics
        • Principal Investigator:
          • Roni Kraut, Dr.
        • Sub-Investigator:
          • Angela Vinturache, Dr.
        • Sub-Investigator:
          • Tatiana Dragan, Dr.
  • Portugal
      • Porto, Portugal
        • Recruiting
        • Centro Hospitalar de São João
        • Principal Investigator:
          • Pedro Vieira-Baptista, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women attending an outpatient clinic with vaginitis symptoms

Description

Inclusion Criteria:

  • Vaginitis symptoms
  • Predominately lactobacilli or/and elongated lactobacilli on wet mount
  • Cytolysis on wet mount

Exclusion Criteria:

  • Unable to consent or decline consent
  • Pregnant
  • Positive for yeast (culture or PCR)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women diagnosed with cytolytic vaginosis
Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize cytolytic vaginosis
Time Frame: 1 year
Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00122929

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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