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

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044156
• Other study ID #: Usak State Hospital
• Status: Completed
• Start date: October 21, 2021
• Est. completion date: March 6, 2022

Study information

• Verified date: March 2022
• Source: Usak State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 6, 2022
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

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Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginal Infection

Intervention

Other:
• salivary sample
salivary sample

Locations

Country	Name	City	State
Turkey	Irem Senyuva	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak State Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

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