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Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

Primary Purpose

Bacterial Vaginoses

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal hygiene wash
placebo wash
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginoses focused on measuring vaginal hygiene wash, bacterial vaginosis, microbial analysis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    Hygiene wash plus metronidazole

    placebo wash plus metronidazole

    Healthy control

    Arm Description

    Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week

    Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week

    Asymptomatic healthy women with BV negative test

    Outcomes

    Primary Outcome Measures

    Bacterial vaginosis cure rate
    Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment
    Visual analog scale of symptoms before treatment
    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
    Visual analog scale of symptoms after treatment
    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
    Microbial profile of vaginal flora before treatment
    DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis
    Microbial profile of vaginal flora after treatment
    DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis
    Cytokines concentration before treatment
    Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline
    Cytokines concentration after treatment
    Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/ml after completed treatment

    Secondary Outcome Measures

    Recurrence of symptoms 1 month after completed treatment
    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
    Microbial analysis of vaginal flora 1 month after completed treatment
    DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis

    Full Information

    First Posted
    April 13, 2021
    Last Updated
    April 26, 2021
    Sponsor
    Universiti Kebangsaan Malaysia Medical Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04846361
    Brief Title
    Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis
    Official Title
    The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universiti Kebangsaan Malaysia Medical Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginoses
    Keywords
    vaginal hygiene wash, bacterial vaginosis, microbial analysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    hygiene wash plus antibiotic, placebo wash plus antibiotic
    Masking
    ParticipantInvestigator
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hygiene wash plus metronidazole
    Arm Type
    Experimental
    Arm Description
    Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
    Arm Title
    placebo wash plus metronidazole
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
    Arm Title
    Healthy control
    Arm Type
    No Intervention
    Arm Description
    Asymptomatic healthy women with BV negative test
    Intervention Type
    Other
    Intervention Name(s)
    Vaginal hygiene wash
    Intervention 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
    Intervention Type
    Other
    Intervention Name(s)
    placebo wash
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Bacterial vaginosis cure rate
    Description
    Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment
    Time Frame
    2 weeks after treatment
    Title
    Visual analog scale of symptoms 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
    Time Frame
    before treatment
    Title
    Visual analog scale of symptoms 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
    Time Frame
    2 weeks after treatment
    Title
    Microbial profile of vaginal flora 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
    Time Frame
    Before treatment
    Title
    Microbial profile of vaginal flora 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
    Time Frame
    2 weeks after treatment
    Title
    Cytokines concentration before treatment
    Description
    Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline
    Time Frame
    before treatment
    Title
    Cytokines concentration 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
    Time Frame
    2 weeks after treatment
    Secondary Outcome Measure Information:
    Title
    Recurrence of symptoms 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
    Time Frame
    1 month after completed treatment
    Title
    Microbial analysis of vaginal flora 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
    Time Frame
    1 month after completed treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    non-pregnant women with bacterial vaginosis
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nurliyana Abdul Razak
    Phone
    60391455555
    Ext
    5950
    Email
    lilin_yana@yahoo.co.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Izyan Atiqah Zakaria, B.Med
    Phone
    60391455555
    Ext
    5950
    Email
    yantz2002@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nur Azurah Abdul Ghani
    Organizational Affiliation
    The National University of Malaysia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    clinical data sheet containing demographics, data collection (VAS score of symptoms, BV blue test)
    IPD Sharing Time Frame
    20 months
    Citations:
    PubMed Identifier
    21251190
    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.
    Results Reference
    background
    PubMed Identifier
    27183928
    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.
    Results Reference
    background
    PubMed Identifier
    22655031
    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.
    Results Reference
    background
    PubMed Identifier
    29674641
    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.
    Results Reference
    background
    PubMed Identifier
    29637269
    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.
    Results Reference
    result
    PubMed Identifier
    21876923
    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.
    Results Reference
    result

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    Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

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