Candidiasis, VulvovaginalEarly Phase 1THRIVE-yeastNCT04930107
Vulvovaginal Candidiasis in Canadian Females
A Early Phase 1 study testing Fluconazole 150 mg and Boric Acid Supp,Vag in people with Candidiasis, Vulvovaginal, run by University of Manitoba at 1 site in Canada.
Trial summary
Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. 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
- Candidiasis, Vulvovaginal
- What is being tested?
- Fluconazole 150 mg and Boric Acid Supp,Vag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 7 Dec 2021to 30 Apr 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Female
- Between ages of 18 and 50 years.
Who cannot join
- Currently pregnant
- Trying to get pregnant
- Have had a hysterectomy
- BV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Studies of Vaginal Yeast and Microbiome Related to Vulvovaginal Candidiasis in Canadian Females
Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes of recurrent infections is that approximately one in five females have vaginal yeast present without any symptoms at any given point. The link between fungi, other microbes in the vagina ("microbiome"), and the human immune system remain poorly understood in the switch from having yeast present in the vagina without any symptoms and symptomatic yeast infections. Fungi also compose a normal component of the microbiome at other sites in the body (e.g., oral, skin, gastrointestinal tract, rectum) where they may serve as a source of re-infection following treatment.
In addition to the commonly prescribed 'first choice' antifungal drug fluconazole, a second-line treatment, boric acid, has shown promise in the literature and has been used locally with success at increasing the time between recurrent infections. A drawback of this therapy, however, is cost, as it is a compounded medication, and patients have to pay out of pocket. The purpose of this study is to understand how the yeast and bacterial microbial communities differ for females with recurrent infections from females with their first yeast infection and females with vaginal yeast present without any symptoms, and to track yeast diversity following treatment with either boric acid or fluconazole. The investigators hypothesize that they will identify multiple subpopulations of yeast at multiple anatomical body sites in females with VVC and recurrent VVC. They anticipate finding evidence for recurrent infection from secondary sites by linking genomic diversity of vaginal yeast strains during symptomatic infection to strains from other body sites. They hypothesize that yeast isolated from females with recurrent infections will exhibit different drug response phenotypes than yeast from females with asymptomatic vaginal yeast. They hypothesize that the vaginal microbiome of post-treatment patients treated with boric acid will differ from that of fluconazole. Combined, they hypothesize that post-treatment response will differ between the drugs, indicating that treatment specifics influence the vaginal environment.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Fluconazole 150 mg, Boric Acid Supp,Vag
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole 150 mgDrug
Treatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Females presenting with a suspected first-time yeast infection will be treated with fluconazole 150 mg orally.
Boric Acid Supp,VagDrug
Treatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Women that have had a prior documented VVC infection that has recurred on fluconazole will be treated with boric acid, 600 mg intravaginally at bedtime for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Infection Cohort - symptomatic | Active comparator | Participants with a history of recurrent vulvovaginal candidiasis infections who have an active symptomatic infection when they come to clinic Receives: Drug: Fluconazole 150 mg; Drug: Boric Acid Supp,Vag |
| Asymptomatic Cohort | No intervention | Participants with no history of vulvovaginal candidiasis |
| Recurrent Infection Cohort - asymptomatic | No intervention | Participants with a history of recurrent vulvovaginal candidiasis infections who do not have an active symptomatic infection when they come to clinic |
| Suspected first VVC infection | Active comparator | Suspected first VVC infection. Intervention as per standard of care. Receives: Drug: Fluconazole 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fungal Diversity
Use culture-based methods, flow cytometry, and genome sequencing to:
- Test how genotypic diversity, genetic relatedness, and drug resistance and tolerance changes in the fungal population from the assumed first-time infection cohort and recurrent infection cohort participants before and after treatment with either fluconazole or boric acid.
- How the vaginal fungal population diversity differs between symptomatic and asymptomatic participants.
- Test how the vaginal fungal isolates in participants with VVC are related to rectal, oral, and skin fungal isolates.
Measured: One month
Secondary outcomes (3)
Bacterial Diversity
Using 16S-rRNA sequencing and meta-proteomic to characterize the bacterial diversity changes pre-and post- drug treatment for VVC.
Measured: One month
Host Functional Changes
Host proteome of the vaginal samples will be assessed using proteomics to determine any underlying inflammatory or barrier pathways that associate with treatment of VVC.
Measured: One month
Phage and mycovirus diversity
Using WGS sequencing to characterize the phage and mycovirus diversity pre-and post- drug treatment for VVC and among different trial arms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 Dec 2021
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation, Research Manitoba
- Responsible party
- Principal investigator, Aleeza Gerstein, University of Manitoba
- Investigators
- Aleeza Gerstein, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930107
- Sponsor's protocol ID
- B2021:026
- Acronym
- THRIVE-yeast
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified proteomics and microbiome data collected will be placed into a freely available data repository after peer review of publications via Genbank. The proteomic expression data shall be made available by depositing the raw, untransformed and normalized counts on our servers. Whole genome sequencing data will be made available on the National Center for Biotechnology Information (NCBI) short reads archive. Any other functional data shall be made available with the journal publications in the text, or as supplementary material at the publisher's online website, or in data repositories (e.g., Dryad, https://datadryad.org).
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studies of Vaginal Yeast and Microbiome Related to Vulvovaginal Candidiasis in Canadian Females
- ClinicalTrials.gov ID
- NCT04930107
- Acronym / sponsor ID
- THRIVE-yeast / B2021:026
- Conditions
- Candidiasis, Vulvovaginal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation, Research Manitoba
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 18 Jun 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.
Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes of recurrent infections is that approximately one in five females have vaginal yeast present without any symptoms at any given point. The link between fungi, other microbes in the vagina ("microbiome"), and the human immune system remain poorly understood in the switch from having yeast present in the vagina without any symptoms and symptomatic yeast infections. Fungi also compose a normal component of the microbiome at other sites in the body (e.g., oral, skin, gastrointestinal tract, rectum) where they may serve as a source of re-infection following treatment.
In addition to the commonly prescribed 'first choice' antifungal drug fluconazole, a second-line treatment, boric acid, has shown promise in the literature and has been used locally with success at increasing the time between recurrent infections. A drawback of this therapy, however, is cost, as it is a compounded medication, and patients have to pay out of pocket. The purpose of this study is to understand how the yeast and bacterial microbial communities differ for females with recurrent infections from females with their first yeast infection and females with vaginal yeast present without any symptoms, and to track yeast diversity following treatment with either boric acid or fluconazole. The investigators hypothesize that they will identify multiple subpopulations of yeast at multiple anatomical body sites in females with VVC and recurrent VVC. They anticipate finding evidence for recurrent infection from secondary sites by linking genomic diversity of vaginal yeast strains during symptomatic infection to strains from other body sites. They hypothesize that yeast isolated from females with recurrent infections will exhibit different drug response phenotypes than yeast from females with asymptomatic vaginal yeast. They hypothesize that the vaginal microbiome of post-treatment patients treated with boric acid will differ from that of fluconazole. Combined, they hypothesize that post-treatment response will differ between the drugs, indicating that treatment specifics influence the vaginal environment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recurrent Infection Cohort - symptomatic | Active comparator | Drug: Fluconazole 150 mg, Drug: Boric Acid Supp,VagParticipants with a history of recurrent vulvovaginal candidiasis infections who have an active symptomatic infection when they come to clinic |
| Asymptomatic Cohort | No intervention | –Participants with no history of vulvovaginal candidiasis |
| Recurrent Infection Cohort - asymptomatic | No intervention | –Participants with a history of recurrent vulvovaginal candidiasis infections who do not have an active symptomatic infection when they come to clinic |
| Suspected first VVC infection | Active comparator | Drug: Fluconazole 150 mgSuspected first VVC infection. Intervention as per standard of care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Between ages of 18 and 50 years.
Key exclusion criteria (4 listed)
- Currently pregnant
- Trying to get pregnant
- Have had a hysterectomy
- BV infection
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 |
|---|---|---|
| Fluconazole 150 mgTreatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Females presenting with a suspected first-time yeast infection will be treated with fluconazole 150 mg orally. | Drug | Recurrent Infection Cohort - symptomatic, Suspected first VVC infection |
| Boric Acid Supp,VagTreatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Women that have had a prior documented VVC infection that has recurred on fluconazole will be treated with boric acid, 600 mg intravaginally at bedtime for 7 days. | Drug | Recurrent Infection Cohort - symptomatic |
Primary outcome
Fungal Diversity
Time frame: One month
Use culture-based methods, flow cytometry, and genome sequencing to: * Test how genotypic diversity, genetic relatedness, and drug resistance and tolerance changes in the fungal population from the assumed first-time infection cohort and recurrent infection cohort participants before and after treatment with either fluconazole or boric acid. * How the vaginal fungal population diversity differs between symptomatic and asymptomatic participants. * Test how the vaginal fungal isolates in participants with VVC are related to rectal, oral, and skin fungal isolates.
3 secondary outcomes
Bacterial Diversity
Time frame: One month
Host Functional Changes
Time frame: One month
Phage and mycovirus diversity
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. De-identified proteomics and microbiome data collected will be placed into a freely available data repository after peer review of publications via Genbank. The proteomic expression data shall be made available by depositing the raw, untransformed and normalized counts on our servers. Whole genome sequencing data will be made available on the National Center for Biotechnology Information (NCBI) short reads archive. Any other functional data shall be made available with the journal publications in the text, or as supplementary material at the publisher's online website, or in data repositories (e.g., Dryad, https://datadryad.org).
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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.
Aleeza Gerstein, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluconazole 150 mg and Boric Acid Supp,Vag in people with Candidiasis, Vulvovaginal, run by University of Manitoba at 1 site in Canada.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Fungal Diversity (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.