Vaginal and Oral Microbiome Crosstalk

Sponsor
Turku University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02898818
Collaborator
Oulu University Hospital (Other)
520
1
100.4
5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: vaginal and oral swab sample, questionnaire
  • Other: papa smear

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
520 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus
Actual Study Start Date :
Apr 19, 2017
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. microbiome, papa smear [5 years]

    Differences in microbiome and papa smear

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments for previously mentioned reasons
Exclusion Criteria:
  • those not meeting the criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Turku University Hospital Turku Finland 20540

Sponsors and Collaborators

  • Turku University Hospital
  • Oulu University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT02898818
Other Study ID Numbers:
  • T146/2016
First Posted:
Sep 13, 2016
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022