Exploratory Study of Relationships Between Malodor and Urine Metabolomics
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ClinicalTrials.gov Identifier: NCT02683876 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 17, 2016
Last Update Posted
: October 4, 2017
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Condition or disease |
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Nutritional and Metabolic Diseases |
Study Type : | Observational |
Actual Enrollment : | 54 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
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 |
Estimated Study Completion Date : | May 2018 |

Group/Cohort |
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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
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Healthy control
individuals not complaining of uncontrollable or unpredictable malodor episodes
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- Differences in metabolite concentrations measured by mass spectrometry, comparing urine samples from individuals with malodor issues, and age-matched healthy controls. [ Time Frame: ten months ]The investigators would like to validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with malodor
- Correlations between urine biomarkers and frequency/severity of malodor symptoms (questionnaires) [ Time Frame: one year ]The investigators will comprehensively analyze the ability of metabolite levels to discriminate frequent and severe from non-severe malodor symptoms

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

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 | |
MeBO Research | |
Miami, Florida, United States, 33175 | |
Canada, Alberta | |
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 |
Additional Information:
Publications:
Responsible Party: | Mebo Research, Inc. |
ClinicalTrials.gov Identifier: | NCT02683876 History of Changes |
Other Study ID Numbers: |
201505010014MEBO |
First Posted: | February 17, 2016 Key Record Dates |
Last Update Posted: | October 4, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | to prevent risks of re-identification. |
Keywords provided by Mebo Research, Inc.:
body odor, malodor, halitosis |
Additional relevant MeSH terms:
Metabolic Diseases |