Clinical trial NCT04846361: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bacterial Vaginoses
Keywords: vaginal hygiene wash
bacterial vaginosis
microbial analysis
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hygiene wash plus antibiotic, placebo wash plus antibiotic
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Bacterial vaginosis cure rate
timeFrame: 2 weeks after treatment
measure: Visual analog scale of symptoms before treatment
timeFrame: before treatment
measure: Visual analog scale of symptoms after treatment
timeFrame: 2 weeks after treatment
measure: Microbial profile of vaginal flora before treatment
timeFrame: Before treatment
measure: Microbial profile of vaginal flora after treatment
timeFrame: 2 weeks after treatment
measure: Cytokines concentration before treatment
timeFrame: before treatment
measure: Cytokines concentration after treatment
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Recurrence of symptoms 1 month after completed treatment
timeFrame: 1 month after completed treatment
measure: Microbial analysis of vaginal flora 1 month after completed treatment
timeFrame: 1 month after completed treatment
Other outcomes:
Locations:
Study officials:
affiliation: The National University of Malaysia
name: Nur Azurah Abdul Ghani
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.