Bacterial VaginosisVMBNCT02459665

Rwanda Vaginal Microbiota Restoration Study

A study testing Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence, Prophylactic use of metronidazole pills (500 mg) and Vaginal Lcr35-containing probiotic for prevention of BV recurrence in people with Bacterial Vaginosis, run by Janneke van de Wijgert.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Bacterial Vaginosis
What is being tested?: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence, Prophylactic use of metronidazole pills (500 mg) and Vaginal Lcr35-containing probiotic for prevention of BV recurrence
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: No sites listed yet
Study dates: 5 Jun 2015to 6 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Sexually active, defined as having had sex at least twice in the two weeks prior to screening
At high risk of HIV/STIs/BV, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI and/or BV in the last 12 months
Successfully treated for BV (modified Amsel criteria) or TV (wet mount), and free of STIs, symptomatic vaginal candidiasis and UTI at enrollment
Currently in good physical and mental health as judged by a study physician
Willing and able to adhere to study procedures and provide written informed consent.

Who cannot join

Pregnant
HIV positive
Clinician-observed genital ulcers, condylomata, or other genital abnormalities at screening or enrollment
Underwent a gynaecological surgery/invasive procedure in the 3 months prior to screening
History of significant urogenital prolapse, undiagnosed vaginal bleeding, urine or faecal incontinence, or blood clotting disorders
Allergic to metronidazole or any other components of the study drugs

Show all 9Show fewer

Not willing to stop use of other oral or vaginal probiotics from the screening visit until the end of study participation
Participating in another health intervention study
For any other reason potentially interfering with participant safety or protocol adherence as judged by the Principal Investigator

About this study

Official title: Preparing for a Clinical Trial of Interventions to Maintain Normal Vaginal Microbiota for Preventing Adverse Reproductive Health Outcomes in Africa

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

Read the detailed description

This is a pilot study to prepare for larger clinical trials. Sixty-eight HIV-negative, non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV, by modified Amsel criteria and/or Nugent score) and/or Trichomonas vaginalis (TV, on wet mount or by culture) will be treated using oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal candidiasis, other curable sexually transmitted infections (STIs) and urinary tract infection (UTI)), they will be randomised to 4 different vaginal microbiome (VMB) maintenance interventions (17 per group) within 3 days of completing oral metronidazole treatment: 1) Behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2) Behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3) Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5 days immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4) Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days for two months. Vaginal probiotic use may be ceased temporarily during menstruation. Participants will be asked to adhere to the interventions for 2 months, and VMB assessments will take place before (screening and enrolment visits), during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).

Conditions: Bacterial Vaginosis
Being tested: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence, Prophylactic use of metronidazole pills (500 mg), Vaginal Lcr35-containing probiotic for prevention of BV recurrence
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 multiple lactobacilli-containing probiotic for prevention of BV recurrenceBiological
Also called Ecologic Femi+ vaginal capsule
Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
Prophylactic use of metronidazole pills (500 mg)Drug
Also called Tricozole
Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV
Vaginal Lcr35-containing probiotic for prevention of BV recurrenceBiological
Also called Gynophilus LP vaginal tablet
Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Study groups in NCT02459665
Study group	Role	What they receive
Group 1	No intervention	Negative control group: After initial treatment for BV/TV, no intervention.
Group 2	Other	Positive control group: After initial treatment for BV/TV, metronidazole pills (500 mg) twice per week for 2 months. Receives: Drug: Prophylactic use of metronidazole pills (500 mg)
Group 3	Active comparator	After initial treatment for BV/TV, Ecologic Femi+ vaginal capsule (a vaginal probiotic) once per day for 5 days immediately after the initial treatment followed by thrice weekly for two months. Receives: Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence
Group 4	Active comparator	After initial treatment for BV/TV, Gynophilus LP vaginal tablet (a vaginal probiotic) once every 4 days for two months. Receives: Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria
Modified Amsel criteria positive is at least 2 of 3 of the following positive: clue cells, vaginal pH, whiff test.
Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as denominator of each incidence rate.
Measured: 2 months (intervention period)
Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10)
The Nugent score is a scale from 0-10 based on visualisation of three different bacterial morphotypes on a Gram stained slide, but in the incidence rates, the variable was used as a binary variable: BV present (Nugent score 7-10) or absent (Nugent score 0-6). Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as the denominator for each incidence rate.
Measured: 2 months (intervention period)
Trichomonas Vaginalis (TV) Incidence by Culture
A swab was inoculated into an InPouch culture pouch, specifically designed for TV growth. The pouch was checked daily for five days to detect growth. The results was positive when growth detected and negative when no growth detected on the fifth day.
Intent-to-treat (ITT) analyses, using person-years (PY) at risk as the denominator for each incidence rate.
Measured: 2 months (intervention period)
Vaginal Candidiasis Incidence by Wet Mount Microscopy
A wet mount is a smear of vaginal fluid on a microscopy slide, which is examined under a microscope. Yeasts are visible without staining. The definition of vaginal candidiasis was any yeast visible on the wet mount. Symptomatic vaginal candidiasis was considered a safety outcome because treatment of bacterial vaginosis often results in vaginal candidiasis. Intent-to-treat (ITT) analysis with person-years (PY) at risk as the denominator of all incidence rates.
Measured: 6 months: 2 months intervention period plus 4 months after intervention cessation

Secondary outcomes (1)

Vaginal Microbiota Composition by Illumina HiSeq Sequencing: Lactobacillus Genus Concentration
The vaginal microbiota sequencing results are exploratory and full data can be found in a manuscript on the BioRxiv preprint server. The most important outcome is the concentration of Lactobacillus genus in vaginal samples taken at the end of the intervention period (M2 visit).
Measured: 2 months (intervention period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 20156 Aug 2018

First posted2 Jun 2015 (estimated)
Study start5 Jun 2015
Primary completion23 Feb 2016
Study completion6 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Bacterial VaginosisStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02459665
Sponsor's protocol ID: RETH000828
Acronym: VMB
Status last verified: Jun 2019
First submitted: 21 May 2015
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Verwijs MC, Agaba S, Umulisa MM, van de Wijgert JHHM. Feasibility and acceptability of frequent vaginal self-sampling at home by Rwandan women at high risk of urogenital tract infections. Sex Transm Infect. 2022 Feb;98(1):58-61. doi: 10.1136/sextrans-2020-054816. Epub 2021 Jan 29.
PubMed 33514681
Verwijs MC, Agaba S, Umulisa MM, Uwineza M, Nivoliez A, Lievens E, van de Wijgert JHHM. Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach. BMJ Open. 2020 May 19;10(5):e031819. doi: 10.1136/bmjopen-2019-031819.
PubMed 32434932
Verwijs MC, Agaba SK, Darby AC, van de Wijgert JHHM. Impact of oral metronidazole treatment on the vaginal microbiota and correlates of treatment failure. Am J Obstet Gynecol. 2020 Feb;222(2):157.e1-157.e13. doi: 10.1016/j.ajog.2019.08.008. Epub 2019 Aug 9.
PubMed 31404542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preparing for a Clinical Trial of Interventions to Maintain Normal Vaginal Microbiota for Preventing Adverse Reproductive Health Outcomes in Africa
ClinicalTrials.gov ID: NCT02459665
Acronym / sponsor ID: VMB / RETH000828
Conditions: Bacterial Vaginosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Janneke van de WijgertUniversity, hospital or other
Collaborators: Rinda Ubuzima, Rwanda
Study start: 5 Jun 2015 (actual)
Primary completion: 23 Feb 2016 (actual)
Study completion: 6 Aug 2018 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1	No intervention	–Negative control group: After initial treatment for BV/TV, no intervention.
Group 2	Other	Drug: Prophylactic use of metronidazole pills (500 mg)Positive control group: After initial treatment for BV/TV, metronidazole pills (500 mg) twice per week for 2 months.
Group 3	Active comparator	Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrenceAfter initial treatment for BV/TV, Ecologic Femi+ vaginal capsule (a vaginal probiotic) once per day for 5 days immediately after the initial treatment followed by thrice weekly for two months.
Group 4	Active comparator	Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrenceAfter initial treatment for BV/TV, Gynophilus LP vaginal tablet (a vaginal probiotic) once every 4 days for two months.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Sexually active, defined as having had sex at least twice in the two weeks prior to screening
At high risk of HIV/STIs/BV, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI and/or BV in the last 12 months
Successfully treated for BV (modified Amsel criteria) or TV (wet mount), and free of STIs, symptomatic vaginal candidiasis and UTI at enrollment
Currently in good physical and mental health as judged by a study physician
Willing and able to adhere to study procedures and provide written informed consent.

Key exclusion criteria (9 listed)

Pregnant
HIV positive
Clinician-observed genital ulcers, condylomata, or other genital abnormalities at screening or enrollment
Underwent a gynaecological surgery/invasive procedure in the 3 months prior to screening
History of significant urogenital prolapse, undiagnosed vaginal bleeding, urine or faecal incontinence, or blood clotting disorders

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 multiple lactobacilli-containing probiotic for prevention of BV recurrenceAlso: Ecologic Femi+ vaginal capsuleVaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV	Biological	Group 3
Prophylactic use of metronidazole pills (500 mg)Also: TricozoleProphylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV	Drug	Group 2
Vaginal Lcr35-containing probiotic for prevention of BV recurrenceAlso: Gynophilus LP vaginal tabletVaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV	Biological	Group 4

Primary outcome

Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria
Time frame: 2 months (intervention period)
Modified Amsel criteria positive is at least 2 of 3 of the following positive: clue cells, vaginal pH, whiff test. Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as denominator of each incidence rate.
Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10)
Time frame: 2 months (intervention period)
The Nugent score is a scale from 0-10 based on visualisation of three different bacterial morphotypes on a Gram stained slide, but in the incidence rates, the variable was used as a binary variable: BV present (Nugent score 7-10) or absent (Nugent score 0-6). Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as the denominator for each incidence rate.
Trichomonas Vaginalis (TV) Incidence by Culture
Time frame: 2 months (intervention period)
A swab was inoculated into an InPouch culture pouch, specifically designed for TV growth. The pouch was checked daily for five days to detect growth. The results was positive when growth detected and negative when no growth detected on the fifth day. Intent-to-treat (ITT) analyses, using person-years (PY) at risk as the denominator for each incidence rate.
Vaginal Candidiasis Incidence by Wet Mount Microscopy
Time frame: 6 months: 2 months intervention period plus 4 months after intervention cessation
A wet mount is a smear of vaginal fluid on a microscopy slide, which is examined under a microscope. Yeasts are visible without staining. The definition of vaginal candidiasis was any yeast visible on the wet mount. Symptomatic vaginal candidiasis was considered a safety outcome because treatment of bacterial vaginosis often results in vaginal candidiasis. Intent-to-treat (ITT) analysis with person-years (PY) at risk as the denominator of all incidence rates.

1 secondary outcome

Vaginal Microbiota Composition by Illumina HiSeq Sequencing: Lactobacillus Genus Concentration
Time frame: 2 months (intervention period)

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	17	17
Oral Metronidazole	17	16
Ecologic Femi+	17	16
Gynophilus LP	17	15

Primary outcome: Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria

Time frame: 2 months (intervention period). Number (95% Confidence Interval). Unit: Incidence: events per PY at risk

Measure	Control n = 15	Oral Metronidazole n = 11	Ecologic Femi+ n = 14	Gynophilus LP n = 11
Value	7.53 (4.28 to 13.26)	2.04 (0.66 to 6.31)	3.36 (1.51 to 7.48)	3.35 (1.26 to 8.92)

Population analysed: Modified ITT population: all randomized women except women with Nugent 7-10 at enrollment.

Primary outcome: Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10)

Time frame: 2 months (intervention period). Number (95% Confidence Interval). Unit: Incidence: events per PY at risk

Measure	Control n = 15	Oral Metronidazole n = 11	Ecologic Femi+ n = 14	Gynophilus LP n = 11
Value	10.18 (5.48 to 18.92)	1.41 (0.35 to 5.62)	3.58 (1.61 to 7.96)	5.36 (2.41 to 11.93)

Population analysed: Modified ITT population: All randomized women except women with Nugent 7-10 at enrollment.

Primary outcome: Trichomonas Vaginalis (TV) Incidence by Culture

Time frame: 2 months (intervention period). Number (95% Confidence Interval). Unit: Incidence: events per PY at risk

Measure	Control Arm n = 17	Metronidazole Arm n = 17	Ecologic Femi+ Arm n = 17	Gynophilus LP Arm n = 16
Value	1.10 (0.35 to 3.41)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: All randomized women except one woman in the Gynophilus LP group who withdrew immediately after enrollment.

Primary outcome: Vaginal Candidiasis Incidence by Wet Mount Microscopy

Time frame: 6 months: 2 months intervention period plus 4 months after intervention cessation. Number (95% Confidence Interval). Unit: Incidence: events per PY at risk

Measure	Control n = 17	Oral Metronidazole n = 17	Ecologic Femi+ n = 17	Gynophilus LP n = 16
Value	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: All randomized women except one woman in the Gynophilus LP group who withdrew immediately after enrollment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months: during the 2-month intervention period and up to 4 months after intervention cessation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 17 (0%)	2 of 17 (11.8%)	0 of 17
Oral Metronidazole	1 of 17 (5.9%)	2 of 17 (11.8%)	0 of 17
Ecologic Femi+	1 of 17 (5.9%)	2 of 17 (11.8%)	0 of 17
Gynophilus LP	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17

Limitations and caveats (from the sponsor): The two most important limitations were the modest sample size (this trial was funded as a pilot trial) and our inability to exclude women with gonorrhea and/or chlamydia infection at the time of randomization (due to slow testing turn-around).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33514681Verwijs MC, Agaba S, Umulisa MM, van de Wijgert JHHM. Feasibility and acceptability of frequent vaginal self-sampling at home by Rwandan women at high risk of urogenital tract infections. Sex Transm Infect. 2022 Feb;98(1):58-61. doi: 10.1136/sextrans-2020-054816. Epub 2021 Jan 29.
Derived from this study: PubMed 32434932Verwijs MC, Agaba S, Umulisa MM, Uwineza M, Nivoliez A, Lievens E, van de Wijgert JHHM. Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach. BMJ Open. 2020 May 19;10(5):e031819. doi: 10.1136/bmjopen-2019-031819.
Derived from this study: PubMed 31404542Verwijs MC, Agaba SK, Darby AC, van de Wijgert JHHM. Impact of oral metronidazole treatment on the vaginal microbiota and correlates of treatment failure. Am J Obstet Gynecol. 2020 Feb;222(2):157.e1-157.e13. doi: 10.1016/j.ajog.2019.08.008. Epub 2019 Aug 9.

Related trials for Bacterial Vaginosis

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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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.

Janneke H van de Wijgert, PhD study chair

University of Liverpool

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2019. 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. 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?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria (time frame: 2 months (intervention period)). The study lists 4 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 NCT02459665, which also lists 3 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 16 Jul 2019.