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临床试验/NCT04930107
NCT04930107进行中(未招募)早期 1 期

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

University of Manitoba2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月7日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleeza Gerstein

Associate Professor

University of Manitoba

研究点 (2)

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