Exploratory Study of Relationships Between Malodor and Urine Metabolomics

Nutritional and Metabolic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683876
• Other study ID #: 201505010014MEBO
• Status: Completed
• Start date: February 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2020
• Source: Mebo Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2018
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Locations

Country	Name	City	State
Canada	The Metabolomics Innovation Centre	Edmonton	Alberta
United States	MeBO Research	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mebo Research, Inc.	University of Alberta

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.	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.	time from diagnostic urine sample collection to dispatch of results
Secondary	Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)	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.	time from sample collection to notification of results and follow-up needed.

External Links

•   Gabashvili, I.S. NCT02683876: Documentation of Clinical Trial Data and Procedures.
•   MeBO Research
•   The Metabolomics Innovation Centre (TMIC)