Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-04-23 @ 6:55 AM
Study NCT ID:
NCT04846361
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "the trial hygiene wash and placebo wash are labelled A or B in identical packaging by manufacturer's company and blinded from both participants and investigators and only revealed at the end of data completion"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'hygiene wash plus antibiotic, placebo wash plus antibiotic'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial vaginosis cure rate', 'timeFrame': '2 weeks after treatment', 'description': 'Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment'}, {'measure': 'Visual analog scale of symptoms before treatment', 'timeFrame': 'before treatment', 'description': 'self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem'}, {'measure': 'Visual analog scale of symptoms after treatment', 'timeFrame': '2 weeks after treatment', 'description': 'self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem'}, {'measure': 'Microbial profile of vaginal flora before treatment', 'timeFrame': 'Before treatment', 'description': 'DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis'}, {'measure': 'Microbial profile of vaginal flora after treatment', 'timeFrame': '2 weeks after treatment', 'description': 'DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis'}, {'measure': 'Cytokines concentration before treatment', 'timeFrame': 'before treatment', 'description': 'Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline'}, {'measure': 'Cytokines concentration after treatment', 'timeFrame': '2 weeks after treatment', 'description': 'Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/ml after completed treatment'}], 'secondaryOutcomes': [{'measure': 'Recurrence of symptoms 1 month after completed treatment', 'timeFrame': '1 month after completed treatment', 'description': 'Self-rated symptoms using visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem'}, {'measure': 'Microbial analysis of vaginal flora 1 month after completed treatment', 'timeFrame': '1 month after completed treatment', 'description': 'DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaginal hygiene wash', 'bacterial vaginosis', 'microbial analysis'], 'conditions': ['Bacterial Vaginoses']}, 'referencesModule': {'references': [{'pmid': '21251190', 'type': 'BACKGROUND', 'citation': 'Lamont RF, Sobel JD, Akins RA, Hassan SS, Chaiworapongsa T, Kusanovic JP, Romero R. The vaginal microbiome: new information about genital tract flora using molecular based techniques. BJOG. 2011 Apr;118(5):533-49. doi: 10.1111/j.1471-0528.2010.02840.x. Epub 2011 Jan 20.'}, {'pmid': '27183928', 'type': 'BACKGROUND', 'citation': 'Eusaph AZ, Nighat R, Arshad A. Lactacyd FH as an adjuvant therapy for vulvovaginal infections in Pakistani women: FRESH study, a satisfaction survey. J Pak Med Assoc. 2016 May;66(5):521-7.'}, {'pmid': '22655031', 'type': 'BACKGROUND', 'citation': 'Bai G, Gajer P, Nandy M, Ma B, Yang H, Sakamoto J, Blanchard MH, Ravel J, Brotman RM. Comparison of storage conditions for human vaginal microbiome studies. PLoS One. 2012;7(5):e36934. doi: 10.1371/journal.pone.0036934. Epub 2012 May 24.'}, {'pmid': '29674641', 'type': 'BACKGROUND', 'citation': 'Hallmaier-Wacker LK, Lueert S, Roos C, Knauf S. The impact of storage buffer, DNA extraction method, and polymerase on microbial analysis. Sci Rep. 2018 Apr 19;8(1):6292. doi: 10.1038/s41598-018-24573-y.'}, {'pmid': '29637269', 'type': 'RESULT', 'citation': 'Russo R, Edu A, De Seta F. Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. Arch Gynecol Obstet. 2018 Jul;298(1):139-145. doi: 10.1007/s00404-018-4771-z. Epub 2018 Apr 10.'}, {'pmid': '21876923', 'type': 'RESULT', 'citation': 'Bahamondes MV, Portugal PM, Brolazo EM, Simoes JA, Bahamondes L. Use of a lactic acid plus lactoserum intimate liquid soap for external hygiene in the prevention of bacterial vaginosis recurrence after metronidazole oral treatment. Rev Assoc Med Bras (1992). 2011 Jul-Aug;57(4):415-20. doi: 10.1590/s0104-42302011000400015.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis', 'detailedDescription': 'This is a randomized controlled trial comparing the trial hygiene wash against placebo wash as adjunct treatment with oral metronidazole in women with bacterial vaginosis, with microbial analysis of vaginal flora compared to healthy control women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'non-pregnant women with bacterial vaginosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. premenopausal women who are sexually active 2.willing to use hygiene wash together with prescribed oral antibiotics 3. able to undergo pelvic examination for sampling of vaginal discharge\n\nExclusion Criteria:\n\n* 1\\. Unable to comply with pelvic examination or hygiene wash 2. Concurrent use of hormonal treatment or antibiotic therapy 3. Intrauterine device either copper or levonorgestrel-releasing system 4. Women with known diabetes mellitus 5. Pregnant women'}, 'identificationModule': {'nctId': 'NCT04846361', 'briefTitle': 'Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis', 'orgStudyIdInfo': {'id': 'FF-2021-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hygiene wash plus metronidazole', 'description': 'Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week', 'interventionNames': ['Other: Vaginal hygiene wash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo wash plus metronidazole', 'description': 'Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week', 'interventionNames': ['Other: placebo wash']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control', 'description': 'Asymptomatic healthy women with BV negative test'}], 'interventions': [{'name': 'Vaginal hygiene wash', 'type': 'OTHER', 'description': 'vaginal hygiene wash containing Propylene Glycol, Ethylhexylglycerin, Lactic Acid, Sodium Pyrrolidone Carboxylic Acid, Alpha-Glucan Oligosaccharide, Lactococcus Ferment Lysate, Octenidine Hydrochloride plus all other ingredients in placebo wash', 'armGroupLabels': ['Hygiene wash plus metronidazole']}, {'name': 'placebo wash', 'type': 'OTHER', 'description': 'placebo wash containing water, disodium cocoamphodiacetate, sodium chloride, sodium glycolate, acrylates copolymer, potassium laureate phosphate, tripotassium phosphate, laurel glucoside, lauramidopropyl hydroxysultaine, disulfonate de sodium, Polyethylene glycol (PEG)-120 Methyl Glucose Trioleate, Propanediol, Glycol distearate, Laureth-4, Cocamidopropyl betaine, Potassium Lactate, Caprylyl Glycol, Disodium ethylenediaminetetraacetic acid (EDTA), Potassium Hydroxide, and Perfume', 'armGroupLabels': ['placebo wash plus metronidazole']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nurliyana Abdul Razak', 'role': 'CONTACT', 'email': 'lilin_yana@yahoo.co.uk', 'phone': '60391455555', 'phoneExt': '5950'}, {'name': 'Izyan Atiqah Zakaria, B.Med', 'role': 'CONTACT', 'email': 'yantz2002@gmail.com', 'phone': '60391455555', 'phoneExt': '5950'}], 'overallOfficials': [{'name': 'Nur Azurah Abdul Ghani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The National University of Malaysia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '20 months', 'ipdSharing': 'YES', 'description': 'clinical data sheet containing demographics, data collection (VAS score of symptoms, BV blue test)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}