Metabolomic Profiling of Urine Samples for the Identification of Novel Biomarkers and Mechanisms in the Diagnosis and Management of Malodor Associated With Metabolic Inefficiencies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
研究概览
简要总结
The purpose of this study is to identify metabolic signatures associated with malodor conditions. The investigators will perform state-of-the art metabolomics tests and bioinformatic data mining to explore if conditions leading to malodor can be screened by metabolomic profiling of urine samples.
详细描述
In this study, metabolite profiling analysis will be carried out on urine samples of individuals with malodor conditions related to metabolism inefficiencies. Metabolic profiles will be identified using the metabolomics equipment located in the NMR, HPLC and MS facilities of the Metabolomics Innovation Centre (TMIC). Multivariate statistical analyses will be used, as well as other approaches to mine complex data from heterogeneous sources.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •unpredictable and uncontrollable episodes of malodor
- •willing and able to ship a urine sample (in the kit provided) by an overnight courier to Edmonton, Alberta, Canada
- •good general health
排除标准
- •serious medical conditions that require treatment
- •conditions that, in the opinion of the investigator, would prevent participation
- •under the age of 18
- •elect not to participate in the study
结局指标
主要结局
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
时间窗: time from diagnostic urine sample collection to dispatch of results
The investigators would like to validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with malodor. Differences in metabolite concentrations will be measured by mass spectrometry, to compare urine samples from individuals with malodor issues, and age-matched healthy controls.
次要结局
- Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)(time from sample collection to notification of results and follow-up needed.)