Vaginal and Oral Microbiome Crosstalk

December 22, 2023 updated by: Turku University Hospital

EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus

To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.

Study Type

Observational

Enrollment (Estimated)

520

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 Contact Backup

Study Locations

  • Finland
      • Turku, Finland, 20540
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Contact:

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients coming to Turku University Hospital Dermato-Venereology Department for venereal disease tests with or without vaginal discharge. Patients coming to Turku University Hospital Gynaecology Department by remission because of atypical papa smear test result or (controls) for some other reason

Description

Inclusion Criteria:

  • patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments for previously mentioned reasons

Exclusion Criteria:

  • those not meeting the criteria

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptomless
vaginal and oral swab sample, questionnaire
Other: vaginal and oral swab sample, questionnaire
vaginal and oral swab sample and questionnaire
vaginal discharge
vaginal and oral swab sample, questionnaire
Other: vaginal and oral swab sample, questionnaire
vaginal and oral swab sample and questionnaire
atypical papa smear
vaginal and oral swab sample, questionnaire, papa smear
Other: vaginal and oral swab sample, questionnaire
vaginal and oral swab sample and questionnaire
Other: papa smear
Papnicolaou Papa Smear test
no atypical papa smear
vaginal and oral swab sample, questionnaire, papa smear
Other: vaginal and oral swab sample, questionnaire
vaginal and oral swab sample and questionnaire
Other: papa smear
Papnicolaou Papa Smear test
lichen planus
vaginal and oral swab sample, questionnaire, papa smear
Other: vaginal and oral swab sample, questionnaire
vaginal and oral swab sample and questionnaire
Other: papa smear
Papnicolaou Papa Smear test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiome, papa smear
Time Frame: 5 years
Differences in microbiome and papa smear
5 years

Collaborators and Investigators

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

Sponsor

Turku University Hospital

Collaborators

Oulu University Hospital

Investigators

  • Principal Investigator: Niina K Hieta, MD, PhD, Specialist

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)

April 19, 2017

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimated)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T146/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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