Exploratory Study of Relationships Between Malodor and Urine Metabolomics
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|ClinicalTrials.gov Identifier: NCT02683876|
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : October 23, 2020
Last Update Posted : October 23, 2020
|Condition or disease|
|Nutritional and Metabolic Diseases|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Metabolomic Profiling of Urine Samples for the Identification of Novel Biomarkers and Mechanisms in the Diagnosis and Management of Malodor Associated With Metabolic Inefficiencies|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||August 30, 2017|
|Actual Study Completion Date :||May 2018|
Subjects with malodor
individuals with self-reported odor issues suspected to be associated with microbial imbalance on or inside the body and inefficient metabolism as evidenced from other laboratory tests
individuals not complaining of uncontrollable or unpredictable malodor episodes
- Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. [ Time Frame: 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.
- Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683876
|United States, Florida|
|Miami, Florida, United States, 33175|
|The Metabolomics Innovation Centre|
|Edmonton, Alberta, Canada, T6G 2E9|
|Principal Investigator:||David Wishart, PhD||The Metabolomics Innovation Centre (TMIC)|
|Principal Investigator:||Irene Gabashvili, PhD||MeBo Research|