Bacterial VaginosesNCT04846361
Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis
A study testing Vaginal hygiene wash in people with Bacterial Vaginoses, run by Universiti Kebangsaan Malaysia Medical Centre.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- Vaginal hygiene wash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis
This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis
Read the 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
- Conditions
- Bacterial Vaginoses
- Being tested
- Vaginal hygiene wash, placebo wash
- Keywords
- vaginal hygiene wash, bacterial vaginosis, microbial analysis
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal hygiene washOther
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 washOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hygiene wash plus metronidazole | Experimental | Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week Receives: 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 Receives: Other: placebo wash |
| Healthy control | No intervention | Asymptomatic healthy women with BV negative test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial vaginosis cure rate
Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks after treatment
Secondary outcomes (2)
Recurrence of symptoms 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
Measured: 1 month after completed treatment
Microbial analysis of vaginal flora 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
Measured: 1 month after completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hygiene wash plus antibiotic, placebo wash plus antibiotic
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nur Azurah Abdul Ghani, Principal investigator, The National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846361
- Sponsor's protocol ID
- FF-2021-031
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: clinical data sheet containing demographics, data collection (VAS score of symptoms, BV blue test)
Publications
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.
PubMed 21251190Eusaph 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.
PubMed 27183928Bai 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.
PubMed 22655031Hallmaier-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.
PubMed 29674641Russo 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.
PubMed 29637269Bahamondes 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.
PubMed 21876923
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis
- ClinicalTrials.gov ID
- NCT04846361
- Acronym / sponsor ID
- FF-2021-031
- Conditions
- Bacterial Vaginoses
- Keywords
- vaginal hygiene wash, bacterial vaginosis, microbial analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- hygiene wash plus antibiotic, placebo wash plus antibiotic
| Arm | Type | Receives |
|---|---|---|
| Hygiene wash plus metronidazole | Experimental | Other: Vaginal hygiene washHygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week |
| placebo wash plus metronidazole | Placebo comparator | Other: placebo washPlacebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week |
| Healthy control | No intervention | –Asymptomatic healthy women with BV negative test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal hygiene washvaginal 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 | Other | Hygiene wash plus metronidazole |
| placebo washplacebo 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 | Other | placebo wash plus metronidazole |
Primary outcome
Bacterial vaginosis cure rate
Time frame: 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
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
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
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
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
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
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
2 secondary outcomes
Recurrence of symptoms 1 month after completed treatment
Time frame: 1 month after completed treatment
Microbial analysis of vaginal flora 1 month after completed treatment
Time frame: 1 month after completed treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 21251190Lamont 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.
- Background: PubMed 27183928Eusaph 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.
- Background: PubMed 22655031Bai 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.
- Background: PubMed 29674641Hallmaier-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.
- Results publication: PubMed 29637269Russo 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.
- Results publication: PubMed 21876923Bahamondes 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.
- Individual participant dataSharing planned: Yes. clinical data sheet containing demographics, data collection (VAS score of symptoms, BV blue test)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Azurah Abdul Ghani principal investigator
The National University of Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal hygiene wash in people with Bacterial Vaginoses, run by Universiti Kebangsaan Malaysia Medical Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurliyana Abdul Razak (60391455555 ext. 5950, lilin_yana@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial vaginosis cure rate (time frame: 2 weeks after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846361, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.