Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women

March 6, 2022 updated by: Irem Senyuva, Usak State Hospital

The low Histatine-5 (HST-5) level of the saliva can lead to vaginal candidiasis. Because HST-5 level in the saliva can effect vaginal Ph, flora and local defence mechanisms.

Histatine-5 is secreted in the parotis and submandibular glands. İt riches histidine amino ascid and have antifungal activity. Salivary proteins and their plasma levels were found as similar in the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women with regularly menstrual cycle will enroll in the study than will separate two groups:

Study group: women with vaginal candidiasis ( diagnosed by clinic and lab.)

Control group: women ( not have any vaginal infections candida and others)

Saliva samples will be taken from two groups than HST-5 level will be analyzed. Finally HST-5 levels of the two groups will be compared .

Women with diabetes, immun deficiency, pregnancy, virgin, menopausal period , premature ovarian failure will be excluded.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

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

Study Locations

  • Turkey
      • Usak, Turkey
        • İrem Şenyuva

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal infection.

Description

Inclusion Criteria: women with regularly menstrual cycle , diagnosed candidal vaginosis and not have any vaginal infection.

-

Exclusion Criteria: diabetes, immun deficiency, menopause, premature ovarian failure, pregnancy, virgin

-

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
Intervention / Treatment
Case group
vaginal candidiasis
Other: salivary sample
salivary sample
Control group
healty women
Other: salivary sample
salivary sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS
Time Frame: 1 month
we done salivary protein electrophoresis( as a small sample group ; consist of vaginal candidiasis and control patients) and Hst5 protein band was seen
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS
Time Frame: 2 month
We found , low salivary Hst5 levels in women with vaginal candidiasis than control group (p=0.001)
2 month

Collaborators and Investigators

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

Sponsor

Usak State Hospital

Investigators

  • Principal Investigator: İREM ŞENYUVA, M.D, Uşak Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 21, 2021

Primary Completion (ACTUAL)

March 6, 2022

Study Completion (ACTUAL)

March 6, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (ACTUAL)

September 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Usak State Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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