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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
Results First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Mebo Research, Inc.

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Nutritional and Metabolic Diseases
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects With Malodor Healthy Control
Hide 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
Reason Not Completed
samples damaged during shipping             2             0
Arm/Group Title Subjects With Malodor Healthy Control Total
Hide 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 Number of Baseline Participants 17 22 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 22 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
21
  95.5%
38
  97.4%
>=65 years
0
   0.0%
1
   4.5%
1
   2.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 22 participants 39 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 17 participants 22 participants 39 participants
17 22 39
Metabolites measured in urine samples  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 22 participants 39 participants
15
  88.2%
22
 100.0%
37
  94.9%
1.Primary Outcome
Title Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects With Malodor Healthy Control
Hide Arm/Group Description:
individuals with self-reported socially debilitating odor episodes
individuals not complaining of uncontrollable or unpredictable malodor episodes
Overall Number of Participants Analyzed 15 22
Mean (Full Range)
Unit of Measure: uMol/mM creatinine
Arginine
3.4
(1.3 to 7.9)
8.6
(1.5 to 18.6)
Citruline
0.443
(0.175 to 1.185)
0.8
(0.2 to 1.7)
Asymmetric dimethylarginine
4.0
(2.8 to 7.0)
3.0
(0.2 to 7.0)
Dopamine
0.18
(0.10 to 0.28)
0.10
(0.066 to 0.30)
Glycine
142.5
(45.4 to 283.0)
101.0
(37.0 to 300.0)
Histamine
0.05
(0.016 to 0.15)
0.03
(0.01 to 0.10)
3-Hydroxytetradecenoylcarnitine
0.0080
(0.001 to 0.087)
0.0020
(0.0008 to 0.0040)
Lysine
4.7
(2.3 to 10.3)
17.9
(3.6 to 56.1)
2.Secondary Outcome
Title Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects With More Severe Disease Subjects With Less Severe Disease
Hide Arm/Group Description:
More severe form of MEBO based on self-reports and prior tests
Subjects with less severe symptoms based on self-reports
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: µmol/mmol creatinine
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)
Time Frame Adverse event data was collected for 6 months after sample collection, 1 year after initial enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects With Malodor Healthy Control
Hide 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 (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Subjects With Malodor Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects With Malodor Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/22 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria De la Torre
Organization: MEBO Research
Phone: 7862286880
EMail: maria.delatorre@meboresearch.org
Publications of Results:
I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223
Layout table for additonal information
Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02683876    
Other Study ID Numbers: 201505010014MEBO
First Submitted: February 3, 2016
First Posted: February 17, 2016
Results First Submitted: September 22, 2020
Results First Posted: October 23, 2020
Last Update Posted: October 23, 2020