Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 8:35 AM
Study NCT ID:
NCT05817292
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Vaginal Microbiota in Women Under Fertile Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014623', 'term': 'Vaginal Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'vaginal discharge'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota', 'timeFrame': 'Baseline; end of the treatment (10 days) ; wash-out (4 weeks)', 'description': 'Change from baseline in the composition of the vaginal microbiota with the increase of the cell density of lactobacilli (at least 3 log units) and decrease of pathogens (at least 2 log units) at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)'}, {'measure': 'Signs', 'timeFrame': 'Baseline; end of the treatment (10 days) ; wash-out (4 weeks)', 'description': "Change from baseline of Amsel's criteria at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)"}, {'measure': 'Signs', 'timeFrame': 'Baseline; end of the treatment (10 days) ; wash-out (4 weeks)', 'description': 'Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)'}, {'measure': 'Symptomatology', 'timeFrame': 'Baseline; end of the treatment (10 days) ; wash-out (4 weeks)', 'description': 'Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching'}], 'secondaryOutcomes': [{'measure': 'Wellbeing', 'timeFrame': 'Baseline; end of the treatment (10 days) ; wash-out (4 weeks)', 'description': 'Change from baseline of the quality of life based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Disease']}, 'descriptionModule': {'briefSummary': 'Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders', 'detailedDescription': 'The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers with vaginal microbiota imbalance', 'genderDescription': 'Women in fertile age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 45 years;\n* Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);\n* Presence of at least 3 Amsel criteria;\n* Nugent score ≥ 7;\n* lactobacillary grade ≥ 2 (LBG) (according to Donders classification);\n* presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy\n\nExclusion Criteria:\n\n* Age \\< 18 years;\n* Nugent score \\< 7;\n* presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;\n* Clinically apparent herpes simplex infection;\n* Human papillomavirus or human immunodeficiency virus infections;\n* Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks;\n* Use of vaginal contraceptives;\n* Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)'}, 'identificationModule': {'nctId': 'NCT05817292', 'acronym': 'vaginalbiota', 'briefTitle': 'Study of the Vaginal Microbiota in Women Under Fertile Age', 'organization': {'class': 'OTHER', 'fullName': 'Universita degli Studi di Catania'}, 'officialTitle': 'Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.', 'orgStudyIdInfo': {'id': '16/2022/PO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Probiotic', 'description': 'Assumption of commercially available supplements containing probiotics', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'label': 'Control', 'description': 'No assumption of supplements containing probiotics', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Assumption of commercial probiotics', 'armGroupLabels': ['Probiotic']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No assumption of probiotics', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'University of Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Antonio Cianci, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Catania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita degli Studi di Catania', 'class': 'OTHER'}, 'collaborators': [{'name': 'ProBioEtna', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Agnese Maria Chiara Rapisarda', 'investigatorAffiliation': 'Universita degli Studi di Catania'}}}}