Exploratory Study of Relationships Between Malodor and Urine Metabolomics

• Sponsor: Mebo Research, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02683876
• Collaborator: University of Alberta (Other)
• Enrollment: 39
• Locations: 2
• Actual Duration (Months): 26.9
• Patients Per Site: 19.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional and Metabolic Diseases

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 Design

• Study Type: Observational
• Actual Enrollment: 39 participants
• 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
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Aug 30, 2017
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. [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 Outcome Measures

1. Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	MeBO Research	Miami	Florida	United States	33175
2	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 3, 2016

More Information

Additional Information:

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

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.

• Responsible Party: Mebo Research, Inc.
• ClinicalTrials.gov Identifier: NCT02683876
• Other Study ID Numbers: 201505010014MEBO
• First Posted: Feb 17, 2016
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mebo Research, Inc.: body odor, malodor, halitosis
• Additional relevant MeSH terms: Metabolic Diseases

Study Results

Participant Flow

Arm/Group Title	Subjects With Malodor	Healthy Control
Arm/Group Description	individuals with self-reported socially debilitating odor episodes	individuals not complaining of uncontrollable or unpredictable malodor episodes
Period Title: Overall Study
STARTED	17	22
COMPLETED	15	22
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Subjects With Malodor	Healthy Control	Total
Arm/Group Description	individuals with self-reported socially debilitating odor episodes	individuals not complaining of uncontrollable or unpredictable malodor episodes	Total of all reporting groups
Overall Participants	17	22	39
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	21 95.5%	38 97.4%
>=65 years	0 0%	1 4.5%	1 2.6%
Sex: Female, Male (Count of Participants)
Female	12 70.6%	8 36.4%	20 51.3%
Male	5 29.4%	14 63.6%	19 48.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	17 100%	22 100%	39 100%
Metabolites measured in urine samples (Count of Participants)
Count of Participants [Participants]	15 88.2%	22 100%	37 94.9%

Outcome Measures

1. Primary Outcome

Title	Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Description	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 Frame	time from diagnostic urine sample collection to dispatch of results

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Malodor	Healthy Control
Arm/Group Description	individuals with self-reported socially debilitating odor episodes	individuals not complaining of uncontrollable or unpredictable malodor episodes
Measure Participants	15	22
Arginine	3.4	8.6
Citruline	0.443	0.8
Asymmetric dimethylarginine	4.0	3.0
Dopamine	0.18	0.10
Glycine	142.5	101.0
Histamine	0.05	0.03
3-Hydroxytetradecenoylcarnitine	0.0080	0.0020
Lysine	4.7	17.9

2. Secondary Outcome

Title	Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Description	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 Frame	time from sample collection to notification of results and follow-up needed.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With More Severe Disease	Subjects With Less Severe Disease
Arm/Group Description	More severe form of MEBO based on self-reports and prior tests	Subjects with less severe symptoms based on self-reports
Measure Participants	9	6
Arginine	3 (2)	3 (2)
Citruline	0.5 (0.3)	0.4 (0.3)
Asymmetric dimethylarginine	4 (2)	3 (1)
Dopamine	0.2 (0.1)	0.2 (0.1)
Glycine	146 (91)	121 (90)
Histamine	0.06 (0.04)	0.04 (0.03)
3-Hydroxytetradecenoylcarnitine	0.012 (0.028)	0.002 (0.001)
Lysine	5 (3)	4 (3)

Adverse Events

Time Frame	Adverse event data was collected for 6 months after sample collection, 1 year after initial enrollment.
Arm/Group Title	Subjects With Malodor		Healthy Control
Arm/Group Description	individuals with self-reported socially debilitating odor episodes		individuals not complaining of uncontrollable or unpredictable malodor episodes
All Cause Mortality
	Subjects With Malodor		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/22 (0%)
Serious Adverse Events
	Subjects With Malodor		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Subjects With Malodor		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.