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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
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Mebo Research, Inc.

Tracking Information
First Submitted Date February 3, 2016
First Posted Date February 17, 2016
Last Update Posted Date June 19, 2018
Actual Study Start Date February 2016
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02683876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 11, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploratory Study of Relationships Between Malodor and Urine Metabolomics
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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism
Condition Nutritional and Metabolic Diseases
Intervention Not Provided
Study 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
Publications * Emwas AH, Roy R, McKay RT, Ryan D, Brennan L, Tenori L, Luchinat C, Gao X, Zeri AC, Gowda GA, Raftery D, Steinbeck C, Salek RM, Wishart DS. Recommendations and Standardization of Biomarker Quantification Using NMR-Based Metabolomics with Particular Focus on Urinary Analysis. J Proteome Res. 2016 Feb 5;15(2):360-73. doi: 10.1021/acs.jproteome.5b00885. Epub 2016 Jan 20. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2018)
39
Original Estimated Enrollment
 (submitted: February 11, 2016)
50
Actual Study Completion Date May 2018
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02683876
Other Study ID Numbers 201505010014MEBO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: to prevent risks of re-identification.
Responsible Party Mebo Research, Inc.
Study Sponsor Mebo Research, Inc.
Collaborators University of Alberta
Investigators
Principal Investigator: David Wishart, PhD The Metabolomics Innovation Centre (TMIC)
Principal Investigator: Irene Gabashvili, PhD MeBo Research
PRS Account Mebo Research, Inc.
Verification Date June 2018