Vulvovaginal Candidiasis in Canadian Females

NCT04930107 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: B2021:026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  One month

Secondary Outcomes (3)

• Bacterial Diversity

  One month

• Host Functional Changes

  One month

• Phage and mycovirus diversity

  1 month

Study Arms (4)

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

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.

Drug: Fluconazole 150 mg

Interventions

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.

Recurrent Infection Cohort - symptomatic; Suspected first VVC infection

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.

Recurrent Infection Cohort - symptomatic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Between ages of 18 and 50 years.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator
• Research Manitoba: collaborator

Study Sites (1)

Health Science Centre (HSC)

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aleeza Gerstein, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Following publication in peer-reviewed journal articles, data available indefinitely.
• Access Criteria: Following publication, external collaborators wishing to make use of THRIVE-yeast data must first contact the PI and submit a written proposal to request access to de-identified data. The PI will consult with University of Manitoba Office of Research Services to create a Data Sharing Transfer Agreement.

Locations

CA (1)