DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using Illumina MiSeq.
研究概览
简要总结
Female-specific health conditions are underrepresented in research. The taboo felt by women to talk about intimate wellbeing is fed by this gender gap in scientific knowledge. This project aims to meet these needs by studying one of the most prevalent female-specific infections, vulvovaginal candidiasis (VVC), and paving the way towards its efficient diagnosis and treatment. About 70% of women worldwide suffer from vaginal candidiasis at least once in their life. An episode of this fungal infection is accompanied by a burning sensation, pain, and reduced mental well-being. Some women (about 5%) encounter such infections at least four times a year, referring to recurrent(R) VVC. The design of efficient diagnostic and therapeutic strategies for (R)VVC is hindered by a knowledge gap surrounding vaginal health. To meet the absolute need for more information, this project will characterize the role of the microbiome, metabolome, immune system, and pathogen characteristics in (R)VVC. To this end, a large sampling platform of women with/without VVC will be established in this project. The researchers will identify the most important and clinically relevant microorganisms, metabolites, and immune factors in VVC pathogenesis. VVC models will be developed and optimized, which will be used to validate the causality of the correlations identified in the cohort. Identified correlations will be proposed as biomarkers, and microbes, metabolites, and combinations, which effectively lower the pathogenicity of Candida species, will be further investigated for therapeutic potential. State-of-the-art tools and know-how of the researchers will allow the unraveling of the involved molecular pathways and elucidate how these can be exploited to optimize therapeutic efficacy. Finally, the knowledge gathered in this project will be used to improve the literacy of women on VVC using platforms established by the researchers as well as novel tools to be developed in this project.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 or older
排除标准
- •Pregnancy
- •Self-reported vaginal complaints (e.g. redness, itching, pain, burning sensation, abnormal vaginal discharge) in the past 12 months (only for healthy group)
- •Use of antibiotics/antifungals in the month prior to sample collection (only for healthy group)
研究组 & 干预措施
Healthy women
Healthy volunteers that do not have vaginal complaints or symptoms, and did not have any in the past 12 months.
干预措施: No intervention (Other)
Women with an acute episode of vulvovaginal candidiasis
Women that have sporadic/acute vulvovaginal Candida infection. It's the first time or the first time in a longer period (1-2 years) that these women have an infection.
干预措施: No intervention (Other)
Women that suffer from recurrent episodes of vulvovaginal candidiasis
These women encounter such infections at least 3 times a year. These women are targeted both during an infection and in between infections.
干预措施: No intervention (Other)
结局指标
主要结局
Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using Illumina MiSeq.
时间窗: up to 4 years
After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyze taxonomic and functional data. The researchers will specifically screen for Candida species (the main causative agent of vulvovaginal candidiasis) and other pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the researchers will also pay attention to health-promoting microorganisms (such as lactic acid bacteria and Saccharomyces species) that are present in the study cohort.
Determining the vaginal metabolic profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using untargeted metabolomics analysis.
时间窗: up to 4 years
Swabs taken by the study cohort will be subjected to high throughput metabolomic analysis, including ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry. The researchers will specifically focus on the differences in the metabolic profile of women with vulvovaginal candidiasis and healthy women. Additionally, the researchers will also pay attention to correlating these metabolic profiles with specific environmental conditions and lifestyle factors.
Determining the vaginal immunological profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using multiplex ELISA assays.
时间窗: up to 4 years
Swabs taken by the study cohort will be subjected to multiplex ELISA assays. More specifically, the researchers will measure the concentration of proinflammatory cytokines known to play a role during vulvovaginal candidiasis (IL-8, IL-1a, IL-1b, IL-6, IFNa, IFNb) and compare this with data from healthy women. Additionally, the researchers will also pay attention to correlating the concentrations of proinflammatory cytokines with specific environmental conditions and lifestyle factors.
Characterizing the pathogenicity of Candida species isolated from women with vulvovaginal candidiasis using semi-high-throughput assays
时间窗: up to 4 years
Candida species isolated from the vagina of women with vulvovaginal candidiasis will be characterized for their pathogenicity. This will involve utilizing spectrophotometry, flow cytometry, and semi-automated image analysis to evaluate aspects such as growth, adhesion to epithelial cells (VK2/E6E7), and filamentation. Additionally, their capacity to cause damage will be assessed by measuring the percentage of lactate dehydrogenase released from epithelial cells through a cytotoxicity assay. Furthermore, the invasion potential of highly damaging strains will be quantified and analyzed in relation to the infection status of the women from whom the isolates were obtained.
Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using shotgun sequencing.
时间窗: up to 4 years
After metagenomic shotgun sequencing, bioinformatic tools will be used to analyze taxonomic and functional data. The researchers will specifically screen for Candida species (the main causative agent of vulvovaginal candidiasis) and other pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the researchers will also pay attention to health-promoting microorganisms (such as lactic acid bacteria and Saccharomyces species) that are present in the study cohort.
次要结局
未报告次要终点