Vaginal InfectionNCT05044156
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
An observational study of Vaginal Infection and Candidiasis, run by Usak State Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection, Candidiasis
- What is being tested?
- salivary sample
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2021to 6 Mar 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal infection.
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vaginal Infection, Candidiasis
- Being tested
- salivary sample
- Medical subject headings
- Vaginitis, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary sampleOther
salivary sample
| Study group | Role | What they receive |
|---|---|---|
| Case group | vaginal candidiasis Receives: Other: salivary sample | |
| Control group | healty women Receives: Other: salivary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start21 Oct 2021
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Usak State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Senyuva, Usak State Hospital
- Investigators
- İREM ŞENYUVA, M.D, Principal investigator, Usak Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044156
- Sponsor's protocol ID
- Usak State Hospital
- Status last verified
- Mar 2022
- First submitted
- 4 Sep 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28223859Loo 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.
PubMed 20739693Liao 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.
PubMed 28645176
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
- ClinicalTrials.gov ID
- NCT05044156
- Acronym / sponsor ID
- Usak State Hospital
- Conditions
- Vaginal Infection, Candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Usak State HospitalUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: salivary samplevaginal candidiasis |
| Control group | – | Other: salivary samplehealty women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary samplesalivary sample | Other | Case group, Control group |
Primary outcome
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 secondary outcome
SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 28223859Khurshid 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.
- Background: PubMed 20739693Loo 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.
- Background: PubMed 28645176Liao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İREM ŞENYUVA, M.D principal investigator
Usak Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Infection and Candidiasis, run by Usak State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044156, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.