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Exploratory Study of Relationships Between Malodor and Urine Metabolomics

Completed
Conditions
Nutritional and Metabolic Diseases
Registration Number
NCT02683876
Lead Sponsor
Mebo Research, Inc.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.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
NameTimeMethod
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)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.

Trial Locations

Locations (2)

MeBO Research

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Miami, Florida, United States

The Metabolomics Innovation Centre

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Edmonton, Alberta, Canada

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