Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT02859493
Status:
TERMINATED
Last Update Posted:
2018-06-13
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'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': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis', 'timeFrame': 'after 7 days and 14 days of treatment', 'description': 'valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Candidiasis, Vulvovaginal']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study. The administration of yeast will be local (vaginal).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria.\n* Amenorrheic subject, or subject having a regular menstrual cycle.\n* Subject psychologically able to understand the study related information and to give a written informed consent.\n* Subject having given freely and expressly her informed consent.\n* Subject able to comply with protocol requirements, as defined in the protocol.\n* Subject affiliated to a health social security system.\n* Female subjects of childbearing potential should use a medically accepted contraceptive regimen (except latex condom, latex diaphragm, spermicidal) during the D0-D14 period, since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end, at the investigator's discretion\n\nExclusion Criteria:\n\nIn terms of population\n\n* Pregnant or nursing woman or planning a pregnancy during the study.\n* Post-menopausal women.\n* Subject who will have her period between the first and the second visit to the gynaecologist (between D0 and D7).\n* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.\n* Subject in a social or sanitary establishment.\n* Subject suspected to be non-compliant according to the investigator's judgment.\n* Subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period, being in an exclusion period for a previous study, having tested a food supplement or a medication in the 4 previous weeks.\n* Subject in an emergency situation. In terms of associated pathology\n* Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.\n* Subject suffering from systemic diseases using concurrent therapy that may interfere with the evaluation of the study results.\n* Subject with a known allergy to one of the component of the study products or to the medication (vaginal ovule and/or antifungal cream).\n* Subject presenting an hypersensitivity to any antifungal of imidazole family or to one of the excipient.\n* Uterine or vaginal bleeding of unknown origin\n* Subject with known sexually transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus or HIV 1 or 2.\n* Immunocompromised subjects\n\nRelating to previous or ongoing treatment\n\n• Subject undergoing a topical treatment on the test area or a systemic or intravaginal treatment:\n\n* antibiotics currently or within the past 2 weeks (systemic antibiotic are accepted if the treatment was stopped until the day before the inclusion visit)\n* anti-fungal agents currently or within the past 2 weeks,\n* anticoagulant within the past 2 weeks and during the study,\n* anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study,\n* corticosteroids during the 2 previous weeks and during the study,\n* retinoids and/or immunosuppressors during the 3 previous months and during the study,\n* any medication stabilized for less than one month.\n\nIn terms of lifestyle\n\n* Subject planning to change her usual hygiene habits and products during the study.\n* Subjects not willing to stop taking probiotics dietary supplements and food products enriched with probiotics."}, 'identificationModule': {'nctId': 'NCT02859493', 'briefTitle': 'Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lesaffre International'}, 'officialTitle': 'Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)', 'orgStudyIdInfo': {'id': '15E2899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Saccharomyces cerevisiae', 'description': 'Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days.', 'interventionNames': ['Device: Saccharomyces cerevisiae']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maize starch and magnesium stearate', 'description': 'Placebo presented in a vaginal capsule. 1 capsule a day for 14 days', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Saccharomyces cerevisiae', 'type': 'DEVICE', 'armGroupLabels': ['Saccharomyces cerevisiae']}, {'name': 'Placebo', 'type': 'DEVICE', 'armGroupLabels': ['Maize starch and magnesium stearate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69100', 'city': 'Villeurbanne', 'country': 'France', 'facility': 'Dermscan', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lesaffre International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}