Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis
NCT ID: NCT04846361
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2021-05-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hygiene wash plus metronidazole
Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
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 wash plus metronidazole
Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week
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
Healthy control
Asymptomatic healthy women with BV negative test
No interventions assigned to this group
Interventions
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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 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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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Universiti Kebangsaan Malaysia Medical Centre
OTHER
Responsible Party
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Principal Investigators
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Nur Azurah Abdul Ghani
Role: PRINCIPAL_INVESTIGATOR
The National University of Malaysia
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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FF-2021-031
Identifier Type: -
Identifier Source: org_study_id
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