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

Sponsor
Usak State Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05044156
Collaborator
(none)
90
1
4.5
20.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: salivary sample

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Actual Study Start Date :
Oct 21, 2021
Actual Primary Completion Date :
Mar 6, 2022
Actual Study Completion Date :
Mar 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Case group

vaginal candidiasis

Other: salivary sample
salivary sample

Control group

healty women

Other: salivary sample
salivary sample

Outcome Measures

Primary Outcome Measures

  1. SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS [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

Secondary Outcome Measures

  1. SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS [2 month]

    We found , low salivary Hst5 levels in women with vaginal candidiasis than control group (p=0.001)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 İrem Şenyuva Usak Turkey

Sponsors and Collaborators

  • Usak State Hospital

Investigators

  • Principal Investigator: İREM ŞENYUVA, M.D, USAK TRAINING AND RESEARCH HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Irem Senyuva, M.D, Obstetrics and Gynecology, Usak State Hospital
ClinicalTrials.gov Identifier:
NCT05044156
Other Study ID Numbers:
  • Usak State Hospital
First Posted:
Sep 14, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022