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NCT Number: NCT04930107

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Health Science Centre (HSC)

Winnipeg, Manitoba, R3A 1R9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Between ages of 18 and 50 years.

Exclusion criteria

  • Currently pregnant
  • Trying to get pregnant
  • Have had a hysterectomy
  • BV infection

Treatment and study plan

Fluconazole 150 mg

Drug

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,Vag

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bacterial Diversity

    Time frame: One month

    Using 16S-rRNA sequencing and meta-proteomic to characterize the bacterial diversity changes pre-and post- drug treatment for VVC.

  2. Host Functional Changes

    Time frame: One month

    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.

  3. Phage and mycovirus diversity

    Time frame: 1 month

    Using WGS sequencing to characterize the phage and mycovirus diversity pre-and post- drug treatment for VVC and among different trial arms.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Medical Service Foundation
  • Research Manitoba

Registry information

Official study title

Prospective Studies of Vaginal Yeast and Microbiome Related to Vulvovaginal Candidiasis in Canadian Females

Acronym: THRIVE-yeast

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Jun 18, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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