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Clinical Trials/NCT02683876
NCT02683876
Completed
Not Applicable

Metabolomic Profiling of Urine Samples for the Identification of Novel Biomarkers and Mechanisms in the Diagnosis and Management of Malodor Associated With Metabolic Inefficiencies

Mebo Research, Inc.2 sites in 2 countries39 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutritional and Metabolic Diseases
Sponsor
Mebo Research, Inc.
Enrollment
39
Locations
2
Primary Endpoint
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
May 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)(time from sample collection to notification of results and follow-up needed.)

Study Sites (2)

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