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| Name | Class |
|---|---|
| University of Alberta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| Healthy control | individuals not complaining of uncontrollable or unpredictable malodor episodes |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | 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. | time from diagnostic urine sample collection to dispatch of results |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | 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. | time from sample collection to notification of results and follow-up needed. |
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Inclusion Criteria:
Exclusion Criteria:
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individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism
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| Name | Affiliation | Role |
|---|---|---|
| David Wishart, PhD | The Metabolomics Innovation Centre (TMIC) | Principal Investigator |
| Irene Gabashvili, PhD | MeBo Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MeBO Research | Miami | Florida | 33175 | United States | ||
| The Metabolomics Innovation Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26745651 | Background | Emwas AH, Roy R, McKay RT, Ryan D, Brennan L, Tenori L, Luchinat C, Gao X, Zeri AC, Gowda GA, Raftery D, Steinbeck C, Salek RM, Wishart DS. Recommendations and Standardization of Biomarker Quantification Using NMR-Based Metabolomics with Particular Focus on Urinary Analysis. J Proteome Res. 2016 Feb 5;15(2):360-73. doi: 10.1021/acs.jproteome.5b00885. Epub 2016 Jan 20. | |
| Result | I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223 |
| Label | URL |
|---|---|
| The Metabolomics Innovation Centre (TMIC) | View source |
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to prevent risks of re-identification.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Malodor | individuals with self-reported socially debilitating odor episodes |
| FG001 | Healthy Control | individuals not complaining of uncontrollable or unpredictable malodor episodes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Malodor | individuals with self-reported socially debilitating odor episodes |
| BG001 | Healthy Control | individuals not complaining of uncontrollable or unpredictable malodor episodes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | 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. | Posted | Mean | Full Range | uMol/mM creatinine | time from diagnostic urine sample collection to dispatch of results |
|
Adverse event data was collected for 6 months after sample collection, 1 year after initial enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Malodor | individuals with self-reported socially debilitating odor episodes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria De la Torre | MEBO Research | 7862286880 | maria.delatorre@meboresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2016 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D000089083 | Body Odor |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| Edmonton |
| Alberta |
| T6G 2E9 |
| Canada |
| MeBO Research | View source |
| Gabashvili, I.S. NCT02683876: Documentation of Clinical Trial Data and Procedures. | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Metabolites measured in urine samples | Count of Participants | Participants |
|
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
|
| Secondary | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | 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. | Posted | Mean | Standard Deviation | µmol/mmol creatinine | time from sample collection to notification of results and follow-up needed. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Healthy Control | individuals not complaining of uncontrollable or unpredictable malodor episodes | 0 | 22 | 0 | 22 | 0 | 22 |
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| Asymmetric dimethylarginine |
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| Dopamine |
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| Glycine |
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| Histamine |
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| 3-Hydroxytetradecenoylcarnitine |
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| Lysine |
|