Trial record 1 of 1 for:
NCT02683876
Exploratory Study of Relationships Between Malodor and Urine Metabolomics
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02683876 |
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Recruitment Status :
Completed
First Posted : February 17, 2016
Last Update Posted : June 19, 2018
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Sponsor:
Mebo Research, Inc.
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Mebo Research, Inc.
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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.
| Condition or disease |
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| Nutritional and Metabolic Diseases |
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.
| Study Type : | Observational |
| Actual Enrollment : | 39 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 |
| Actual Study Completion Date : | May 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Urine and Urination
| 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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Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism
Criteria
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
Information from the National Library of Medicine
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
Locations
| United States, Florida | |
| MeBO Research | |
| Miami, Florida, United States, 33175 | |
| Canada, Alberta | |
| The Metabolomics Innovation Centre | |
| Edmonton, Alberta, Canada, T6G 2E9 | |
Sponsors and Collaborators
Mebo Research, Inc.
University of Alberta
Investigators
| 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: | June 19, 2018 |
| Last Verified: | June 2018 |
| 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.:
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body odor, malodor, halitosis |
Additional relevant MeSH terms:
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Metabolic Diseases |