Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

NCT04846361 | Unknown

• 1 other identifier: FF-2021-031
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bacterial Vaginoses

Keywords

vaginal hygiene wash; bacterial vaginosis; microbial analysis

Outcome Measures

Primary Outcomes (7)

• Bacterial vaginosis cure rate

  Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment

  2 weeks after 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

  before treatment

• 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

  2 weeks after treatment

• 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

  Before treatment

• 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

  2 weeks after treatment

• 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

  before treatment

• 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

  2 weeks after treatment

Secondary Outcomes (2)

• Recurrence of symptoms 1 month after completed treatment

  1 month after completed treatment

• Microbial analysis of vaginal flora 1 month after completed treatment

  1 month after completed treatment

Study Arms (3)

Hygiene wash plus metronidazole

EXPERIMENTAL

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

Other: Vaginal hygiene wash

placebo wash plus metronidazole

PLACEBO COMPARATOR

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

Other: placebo wash

Healthy control

NO INTERVENTION

Asymptomatic healthy women with BV negative test

Interventions

Vaginal hygiene wash OTHER

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

Hygiene wash plus metronidazole

placebo wash OTHER

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

placebo wash plus metronidazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: non-pregnant women with bacterial vaginosis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Related Publications (6)

• 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: 21251190 BACKGROUND

• 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: 27183928 BACKGROUND

• 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: 22655031 BACKGROUND

• 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: 29674641 BACKGROUND

• 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: 29637269 RESULT

• 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.

  PMID: 21876923 RESULT

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Nur Azurah Abdul Ghani

  The National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurliyana Abdul Razak

CONTACT

60391455555; lilin_yana@yahoo.co.uk

Izyan Atiqah Zakaria, B.Med

CONTACT

60391455555; yantz2002@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: hygiene wash plus antibiotic, placebo wash plus antibiotic

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: May 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 20 months