Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05044156
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2021-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D002177', 'term': 'Candidiasis'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-06', 'studyFirstSubmitDate': '2021-09-04', 'studyFirstSubmitQcDate': '2021-09-04', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS', 'timeFrame': '1 month', 'description': 'we done salivary protein electrophoresis( as a small sample group ; consist of vaginal candidiasis and control patients) and Hst5 protein band was seen'}], 'secondaryOutcomes': [{'measure': 'SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS', 'timeFrame': '2 month', 'description': 'We found , low salivary Hst5 levels in women with vaginal candidiasis than control group (p=0.001)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Infection', 'Candidiasis']}, 'referencesModule': {'references': [{'pmid': '28223859', 'type': 'BACKGROUND', 'citation': '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': '20739693', 'type': 'BACKGROUND', '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.'}, {'pmid': '28645176', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHistatine-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.', 'detailedDescription': 'Women with regularly menstrual cycle will enroll in the study than will separate two groups:\n\nStudy group: women with vaginal candidiasis ( diagnosed by clinic and lab.)\n\nControl group: women ( not have any vaginal infections candida and others)\n\nSaliva 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 .\n\nWomen with diabetes, immun deficiency, pregnancy, virgin, menopausal period , premature ovarian failure will be excluded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal infection.', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: women with regularly menstrual cycle , diagnosed candidal vaginosis and not have any vaginal infection.\n\n\\-\n\nExclusion Criteria: diabetes, immun deficiency, menopause, premature ovarian failure, pregnancy, virgin\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05044156', 'briefTitle': 'Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women', 'organization': {'class': 'OTHER', 'fullName': 'Usak State Hospital'}, 'officialTitle': 'Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women', 'orgStudyIdInfo': {'id': 'Usak State Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'vaginal candidiasis', 'interventionNames': ['Other: salivary sample']}, {'label': 'Control group', 'description': 'healty women', 'interventionNames': ['Other: salivary sample']}], 'interventions': [{'name': 'salivary sample', 'type': 'OTHER', 'description': 'salivary sample', 'armGroupLabels': ['Case group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'İrem Şenyuva', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'overallOfficials': [{'name': 'İREM ŞENYUVA, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USAK TRAINING AND RESEARCH HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Usak State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Obstetrics and Gynecology', 'investigatorFullName': 'Irem Senyuva', 'investigatorAffiliation': 'Usak State Hospital'}}}}