Exploratory Study of Relationships Between Malodor and Urine Metabolomics
- Conditions
- Nutritional and Metabolic Diseases
- Registration Number
- NCT02683876
- Lead Sponsor
- Mebo Research, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. 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.
- Secondary Outcome Measures
Name Time Method Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) time from sample collection to notification of results and follow-up needed. The investigators will comprehensively analyze the ability of metabolite levels to discriminate frequent and severe from less severe malodor symptoms. The severity of the disease was assessed trough interviews (frequency of key symptoms) and prior laboratory tests.
Trial Locations
- Locations (2)
MeBO Research
πΊπΈMiami, Florida, United States
The Metabolomics Innovation Centre
π¨π¦Edmonton, Alberta, Canada