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Trial record 1 of 1 for:    NCT02683876
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Exploratory Study of Relationships Between Malodor and Urine Metabolomics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Mebo Research, Inc.
ClinicalTrials.gov Identifier:
NCT02683876
First received: February 3, 2016
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
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
Nutritional and Metabolic Diseases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mebo Research, Inc.:

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


Enrollment: 54
Actual Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02683876     History of Changes
Other Study ID Numbers: 201505010014MEBO
Study First Received: February 3, 2016
Last Updated: July 7, 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

ClinicalTrials.gov processed this record on September 21, 2017