Prospective Studies of Vaginal Yeast and Microbiome Related to Vulvovaginal Candidiasis in Canadian Females
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Fungal Diversity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between ages of 18 and 50 years.
排除标准
- •Currently pregnant
- •Trying to get pregnant
- •Have had a hysterectomy
- •BV infection
研究组 & 干预措施
Recurrent Infection Cohort - symptomatic
Participants with a history of recurrent vulvovaginal candidiasis infections who have an active symptomatic infection when they come to clinic
干预措施: Fluconazole 150 mg (Drug)
Recurrent Infection Cohort - symptomatic
Participants with a history of recurrent vulvovaginal candidiasis infections who have an active symptomatic infection when they come to clinic
干预措施: Boric Acid Supp,Vag (Drug)
Asymptomatic Cohort
Participants with no history of vulvovaginal candidiasis
Recurrent Infection Cohort - asymptomatic
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
Suspected first VVC infection. Intervention as per standard of care.
干预措施: Fluconazole 150 mg (Drug)
结局指标
主要结局
Fungal Diversity
时间窗: 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.
次要结局
- Bacterial Diversity(One month)
- Host Functional Changes(One month)
- Phage and mycovirus diversity(1 month)
研究者
Aleeza Gerstein
Associate Professor
University of Manitoba
