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Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT04846361
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Study Description
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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

Condition or disease Intervention/treatment Phase
Bacterial Vaginoses Other: Vaginal hygiene wash Other: placebo wash Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: hygiene wash plus antibiotic, placebo wash plus antibiotic
Masking: Double (Participant, Investigator)
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
Primary Purpose: Treatment
Official Title: The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hygiene wash plus metronidazole
Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
 Other: Vaginal hygiene wash
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
Placebo Comparator: placebo wash plus metronidazole
Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
 Other: placebo wash
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
No Intervention: Healthy control
Asymptomatic healthy women with BV negative test


Outcome Measures
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Primary Outcome Measures :
  1. Bacterial vaginosis cure rate [ Time Frame: 2 weeks after treatment ]
    Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment

  2. Visual analog scale of symptoms before treatment [ Time Frame: 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

  3. Visual analog scale of symptoms after treatment [ Time Frame: 2 weeks 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

  4. Microbial profile of vaginal flora before treatment [ Time Frame: 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

  5. Microbial profile of vaginal flora after treatment [ Time Frame: 2 weeks 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

  6. Cytokines concentration before treatment [ Time Frame: before treatment ]
    Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline

  7. Cytokines concentration after treatment [ Time Frame: 2 weeks 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 :
  1. Recurrence of symptoms 1 month after completed treatment [ Time Frame: 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

  2. Microbial analysis of vaginal flora 1 month after completed treatment [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   non-pregnant women with bacterial vaginosis
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846361


Contacts
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Contact: Nurliyana Abdul Razak 60391455555 ext 5950 lilin_yana@yahoo.co.uk
Contact: Izyan Atiqah Zakaria, B.Med 60391455555 ext 5950 yantz2002@gmail.com

Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: Nur Azurah Abdul Ghani The National University of Malaysia
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT04846361    
Other Study ID Numbers: FF-2021-031
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: clinical data sheet containing demographics, data collection (VAS score of symptoms, BV blue test)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 20 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universiti Kebangsaan Malaysia Medical Centre:
vaginal hygiene wash
bacterial vaginosis
microbial analysis
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Vaginitis