Vaginal and Oral Microbiome Crosstalk

NCT02898818 | Recruiting

• 1 other identifier: T146/2016
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Vaginal Discharge

Outcome Measures

Primary Outcomes (1)

• microbiome, papa smear

  Differences in microbiome and papa smear

  5 years

Study Arms (5)

symptomless

vaginal and oral swab sample, questionnaire

Other: vaginal and oral swab sample, questionnaire

vaginal discharge

vaginal and oral swab sample, questionnaire

Other: vaginal and oral swab sample, questionnaire

atypical papa smear

vaginal and oral swab sample, questionnaire, papa smear

Other: vaginal and oral swab sample, questionnaire; Other: papa smear

no atypical papa smear

vaginal and oral swab sample, questionnaire, papa smear

Other: vaginal and oral swab sample, questionnaire; Other: papa smear

lichen planus

vaginal and oral swab sample, questionnaire, papa smear

Other: vaginal and oral swab sample, questionnaire; Other: papa smear

Interventions

vaginal and oral swab sample, questionnaire OTHER

vaginal and oral swab sample and questionnaire

atypical papa smear; lichen planus; no atypical papa smear; symptomless; vaginal discharge

papa smear OTHER

Papnicolaou Papa Smear test

atypical papa smear; lichen planus; no atypical papa smear

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. Patients coming to family planning clinics in The wellbeing services county of Southwest Finland.

You may qualify if:

• patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons

You may not qualify if:

• those not meeting the criteria

Sponsors & Collaborators

• Turku University Hospital: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Turku University Hospital

Turku, Turku, 20540, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

swab sample from vaginal ja oral smear, including microbes and epithelial cells

MeSH Terms

Conditions

Vaginal Discharge

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Niina K Hieta, MD, PhD

  specialist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niina K Hieta, MD, PhD

CONTACT

2-3131620; niina.hieta@tyks.fi

Katja M Kero, Md, PhD

CONTACT

2-3130000; katja.kero@tyks.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: April 19, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FI (1)