Exploratory Study of Relationships Between Malodor and Urine Metabolomics

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.

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Key information

Conditions

Nutritional and Metabolic Diseases Body Odor Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Metabolomics Innovation Centre, Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 frame: 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.

Sponsors and collaborators

Lead sponsor

Mebo Research, Inc.

Other

Collaborators

University of Alberta

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Feb 17, 2016
Registry last updated: Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed