NCT02683876

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 23, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

February 3, 2016

Results QC Date

September 22, 2020

Last Update Submit

October 22, 2020

Conditions

Nutritional and Metabolic Diseases

Keywords

body odor, malodor, halitosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)

    time from sample collection to notification of results and follow-up needed.

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MeBO Research

Miami, Florida, 33175, United States

Location

The Metabolomics Innovation Centre

Edmonton, Alberta, T6G 2E9, Canada

Location

Related 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.

    PMID: 26745651BACKGROUND

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

    RESULT

Related Links

MeSH Terms

Conditions

Nutritional and Metabolic DiseasesBody OdorHalitosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Results Point of Contact

Title
Maria De la Torre
Organization
MEBO Research
maria.delatorre@meboresearch.org
7862286880

Study Officials

  • David Wishart, PhD

    The Metabolomics Innovation Centre (TMIC)

    PRINCIPAL INVESTIGATOR

  • Irene Gabashvili, PhD

    MeBo Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 17, 2016

Study Start

February 1, 2016

Primary Completion

August 30, 2017

Study Completion

May 1, 2018

Last Updated

October 23, 2020

Results First Posted

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

to prevent risks of re-identification.

Locations

CA(1)US(1)