Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

Not Applicable

• Conditions: Bacterial Vaginoses
• Interventions: Other: Vaginal hygiene wash; Other: placebo wash

• Registration Number: NCT04846361
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Study Start: 2021-05
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hygiene wash plus metronidazole	Vaginal hygiene wash	Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
placebo wash plus metronidazole	placebo wash	Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week

Primary Outcome Measures

Name	Time	Method
Visual analog scale of symptoms after treatment	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
Microbial profile of vaginal flora before treatment	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
Bacterial vaginosis cure rate	2 weeks after treatment	Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment
Visual analog scale of symptoms before treatment	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
Cytokines concentration before treatment	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	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
Microbial profile of vaginal flora after treatment	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

Secondary Outcome Measures

Name	Time	Method
Microbial analysis of vaginal flora 1 month after completed treatment	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
Recurrence of symptoms 1 month after completed treatment	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