Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT03187457
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-12', 'releaseDate': '2022-11-03'}, {'resetDate': '2024-03-27', 'releaseDate': '2023-10-02'}, {'resetDate': '2024-08-22', 'releaseDate': '2024-04-03'}, {'resetDate': '2024-09-05', 'releaseDate': '2024-09-02'}], 'estimatedResultsFirstSubmitDate': '2022-11-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-12', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vaginal microbiota assessed with sequencing', 'timeFrame': 'Baseline, at day 8, and at day 15', 'description': 'Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)'}], 'secondaryOutcomes': [{'measure': 'Vaginal microbiota/lactobacilli levels with Nugent scoring', 'timeFrame': 'Baseline, at day 8, and at day 15', 'description': 'Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment.'}, {'measure': 'Diagnosis of BV with "Canestest"', 'timeFrame': 'Baseline', 'description': '"Canestest" will be used to diagnose BV infection at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).', 'detailedDescription': 'This method validation study will endeavour to obtain evidence for:\n\n* Recruitment methodology effectiveness\n* The usefulness of the "Canestest" test as a screening tool\n* The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.\n* The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Female gender\n* Over 18 years of age\n* Have a high probability for compliance with and completion of the study\n\nExclusion Criteria:\n\n* Hypersensitivity to metronidazole --only applies to Group 2.\n* Post-menopausal defined as at least 12 consecutive months without menstruation\n* Treatment of BV in last 4 weeks\n* Clinically significant menstrual irregularities\n* Suspected presence of STDs or other vaginal infection\n* Pregnancy\n* Breast feeding\n* Participation in other clinical studies which could influence genitourinary tract microbiota\n* Substance abuse\n* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study'}, 'identificationModule': {'nctId': 'NCT03187457', 'acronym': 'PreFem', 'briefTitle': 'PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danisco'}, 'officialTitle': 'PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"', 'orgStudyIdInfo': {'id': 'NH-03708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment group', 'description': 'Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection', 'interventionNames': ['Other: Metronidazole']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Healthy women without Bacterial Vaginosis and without treatment', 'interventionNames': ['Other: Control: no treatment']}], 'interventions': [{'name': 'Metronidazole', 'type': 'OTHER', 'description': 'Women with Bacterial Vaginosis treated with Metronidazole for 5 days', 'armGroupLabels': ['Treatment group']}, {'name': 'Control: no treatment', 'type': 'OTHER', 'description': 'Healthy women without Bacterial Vaginosis', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G20 0XA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'CPS Research', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Gordon Crawford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPS Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danisco', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Community Pharmacology Services Ltd', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-03', 'type': 'RELEASE'}, {'date': '2023-09-12', 'type': 'RESET'}, {'date': '2023-10-02', 'type': 'RELEASE'}, {'date': '2024-03-27', 'type': 'RESET'}, {'date': '2024-04-03', 'type': 'RELEASE'}, {'date': '2024-08-22', 'type': 'RESET'}, {'date': '2024-09-02', 'type': 'RELEASE'}, {'date': '2024-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Danisco'}}}}