Trial Outcomes & Findings for Exploratory Study of Relationships Between Malodor and Urine Metabolomics (NCT NCT02683876)
NCT ID: NCT02683876
Last Updated: 2020-10-23
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
39 participants
Primary outcome timeframe
time from diagnostic urine sample collection to dispatch of results
Results posted on
2020-10-23
Participant Flow
Participant milestones
| Measure |
Subjects With Malodor
individuals with self-reported socially debilitating odor episodes
|
Healthy Control
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
22
|
|
Overall Study
COMPLETED
|
15
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Subjects With Malodor
individuals with self-reported socially debilitating odor episodes
|
Healthy Control
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
|---|---|---|
|
Overall Study
samples damaged during shipping
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects With Malodor
n=17 Participants
individuals with self-reported socially debilitating odor episodes
|
Healthy Control
n=22 Participants
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
21 Participants
n=22 Participants
|
38 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=17 Participants
|
8 Participants
n=22 Participants
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=17 Participants
|
14 Participants
n=22 Participants
|
19 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
17 participants
n=17 Participants
|
22 participants
n=22 Participants
|
39 participants
n=39 Participants
|
|
Metabolites measured in urine samples
|
15 Participants
n=17 Participants
|
22 Participants
n=22 Participants
|
37 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: time from diagnostic urine sample collection to dispatch of resultsThe 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.
Outcome measures
| Measure |
Subjects With Malodor
n=15 Participants
individuals with self-reported socially debilitating odor episodes
|
Healthy Control
n=22 Participants
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
|---|---|---|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Arginine
|
3.4 uMol/mM creatinine
Interval 1.3 to 7.9
|
8.6 uMol/mM creatinine
Interval 1.5 to 18.6
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Citruline
|
0.443 uMol/mM creatinine
Interval 0.175 to 1.185
|
0.8 uMol/mM creatinine
Interval 0.2 to 1.7
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Asymmetric dimethylarginine
|
4.0 uMol/mM creatinine
Interval 2.8 to 7.0
|
3.0 uMol/mM creatinine
Interval 0.2 to 7.0
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Dopamine
|
0.18 uMol/mM creatinine
Interval 0.1 to 0.28
|
0.10 uMol/mM creatinine
Interval 0.066 to 0.3
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Glycine
|
142.5 uMol/mM creatinine
Interval 45.4 to 283.0
|
101.0 uMol/mM creatinine
Interval 37.0 to 300.0
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Histamine
|
0.05 uMol/mM creatinine
Interval 0.016 to 0.15
|
0.03 uMol/mM creatinine
Interval 0.01 to 0.1
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
3-Hydroxytetradecenoylcarnitine
|
0.0080 uMol/mM creatinine
Interval 0.001 to 0.087
|
0.0020 uMol/mM creatinine
Interval 0.0008 to 0.004
|
|
Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Lysine
|
4.7 uMol/mM creatinine
Interval 2.3 to 10.3
|
17.9 uMol/mM creatinine
Interval 3.6 to 56.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Subjects With Malodor
n=9 Participants
individuals with self-reported socially debilitating odor episodes
|
Healthy Control
n=6 Participants
individuals not complaining of uncontrollable or unpredictable malodor episodes
|
|---|---|---|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Arginine
|
3 µmol/mmol creatinine
Standard Deviation 2
|
3 µmol/mmol creatinine
Standard Deviation 2
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Citruline
|
0.5 µmol/mmol creatinine
Standard Deviation 0.3
|
0.4 µmol/mmol creatinine
Standard Deviation 0.3
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Asymmetric dimethylarginine
|
4 µmol/mmol creatinine
Standard Deviation 2
|
3 µmol/mmol creatinine
Standard Deviation 1
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Dopamine
|
0.2 µmol/mmol creatinine
Standard Deviation 0.1
|
0.2 µmol/mmol creatinine
Standard Deviation 0.1
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Glycine
|
146 µmol/mmol creatinine
Standard Deviation 91
|
121 µmol/mmol creatinine
Standard Deviation 90
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Histamine
|
0.06 µmol/mmol creatinine
Standard Deviation 0.04
|
0.04 µmol/mmol creatinine
Standard Deviation 0.03
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
3-Hydroxytetradecenoylcarnitine
|
0.012 µmol/mmol creatinine
Standard Deviation 0.028
|
0.002 µmol/mmol creatinine
Standard Deviation 0.001
|
|
Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Lysine
|
5 µmol/mmol creatinine
Standard Deviation 3
|
4 µmol/mmol creatinine
Standard Deviation 3
|
Adverse Events
Subjects With Malodor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place