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Trial record 1 of 1 for:    NCT02683876
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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
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Mebo Research, Inc.

Study Description
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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
Nutritional and Metabolic Diseases

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.
Study Design
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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


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Contacts and Locations
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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
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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
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Principal Investigator: David Wishart, PhD The Metabolomics Innovation Centre (TMIC)
Principal Investigator: Irene Gabashvili, PhD MeBo Research
  Study Documents (Full-Text)

Documents provided by Mebo Research, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] February 3, 2016

More Information
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Additional Information:

Publications of Results:
I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223

Other Publications:

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Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02683876    
Other Study ID Numbers: 201505010014MEBO
First Posted: February 17, 2016    Key Record Dates
Results First Posted: October 23, 2020
Last Update Posted: October 23, 2020
Last Verified: October 2020
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:
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Metabolic Diseases