NCT05044156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

September 4, 2021

Last Update Submit

March 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS

    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 Outcomes (1)

  • SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS

    2 month

Study Arms (2)

Case group

vaginal candidiasis

Other: salivary sample

Control group

healty women

Other: salivary sample

Interventions

salivary sample

Case groupControl group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İrem Şenyuva

Uşak, Turkey (Türkiye)

Location

Related Publications (3)

  • Khurshid Z, Najeeb S, Mali M, Moin SF, Raza SQ, Zohaib S, Sefat F, Zafar MS. Histatin peptides: Pharmacological functions and their applications in dentistry. Saudi Pharm J. 2017 Jan;25(1):25-31. doi: 10.1016/j.jsps.2016.04.027. Epub 2016 May 4.

    PMID: 28223859BACKGROUND
  • Loo JA, Yan W, Ramachandran P, Wong DT. Comparative human salivary and plasma proteomes. J Dent Res. 2010 Oct;89(10):1016-23. doi: 10.1177/0022034510380414. Epub 2010 Aug 25.

    PMID: 20739693BACKGROUND
  • Liao H, Liu S, Wang H, Su H, Liu Z. Efficacy of Histatin5 in a murine model of vulvovaginal candidiasis caused by Candida albicans. Pathog Dis. 2017 Aug 31;75(6). doi: 10.1093/femspd/ftx072.

    PMID: 28645176BACKGROUND

MeSH Terms

Conditions

VaginitisCandidiasis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMycosesBacterial Infections and MycosesInfections

Study Officials

  • İREM ŞENYUVA, M.D

    USAK TRAINING AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Obstetrics and Gynecology

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 14, 2021

Study Start

October 21, 2021

Primary Completion

March 6, 2022

Study Completion

March 6, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations