Trial Outcomes & Findings for Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis (NCT NCT02692495)
NCT ID: NCT02692495
Last Updated: 2018-02-22
Results Overview
The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.
Recruitment status
COMPLETED
Target enrollment
16 participants
Primary outcome timeframe
four years
Results posted on
2018-02-22
Participant Flow
Participant milestones
| Measure |
Body Odor
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
individuals with halitosis (bad breath), not complaining of body odors
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis
Baseline characteristics by cohort
| Measure |
Body Odor
n=12 Participants
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
n=4 Participants
individuals with halitosis, not complaining of body odors
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
37.5 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
32.6 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=93 Participants
|
4 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Duration of condition
Age at onset of symptoms
|
21 years
STANDARD_DEVIATION 9 • n=93 Participants
|
29 years
STANDARD_DEVIATION 9 • n=4 Participants
|
23 years
STANDARD_DEVIATION 9 • n=27 Participants
|
|
Duration of condition
Duration of symptoms
|
9 years
STANDARD_DEVIATION 6 • n=93 Participants
|
9 years
STANDARD_DEVIATION 5 • n=4 Participants
|
9 years
STANDARD_DEVIATION 6 • n=27 Participants
|
PRIMARY outcome
Timeframe: four yearsThe investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.
Outcome measures
| Measure |
Body Odor
n=12 Participants
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
n=4 Participants
individuals with halitosis, not complaining of body odors
|
"Lactic" Subgroup
"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)
|
|---|---|---|---|
|
Number of Test Results Outside the Normal Range
Elevated blood ethanol
|
6 participants
|
3 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated blood methanol
|
0 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 1-propanol
|
8 participants
|
3 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-propanol
|
3 participants
|
3 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-methyl-1-propanol
|
6 participants
|
2 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-methyl-2-propanol
|
0 participants
|
1 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 1-butanol
|
1 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-butanol
|
2 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-methyl-1-butanol
|
6 participants
|
1 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-methyl-2-butanol
|
0 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2-ethyl-1-butanol
|
0 participants
|
1 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Elevated 2,3-butylene glycol
|
4 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Increased blood acetate
|
0 participants
|
1 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Decreased blood acetate
|
4 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Decreased blood propionate
|
4 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Decreased blood butyrate
|
5 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Blood Succinate out of range
|
0 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Blood Valerate out of range
|
0 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Increased gut permeability
|
9 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
Decreased gut permeability
|
0 participants
|
2 participants
|
—
|
|
Number of Test Results Outside the Normal Range
increased blood D-lactate
|
3 participants
|
0 participants
|
—
|
|
Number of Test Results Outside the Normal Range
increased urine Indicans
|
5 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: three yearsThe investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters ("Sour" and "Sweet") shown below along with the "Lactic" subgroup from the "Sour" group.
Outcome measures
| Measure |
Body Odor
n=7 Participants
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
n=7 Participants
individuals with halitosis, not complaining of body odors
|
"Lactic" Subgroup
n=2 Participants
"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)
|
|---|---|---|---|
|
Discriminative Biomarkers in the Subgroups of Malodor
D-lactate
|
7 umol/L
Standard Deviation 5
|
29 umol/L
Standard Deviation 39
|
330 umol/L
Standard Deviation 245
|
|
Discriminative Biomarkers in the Subgroups of Malodor
2- butanol
|
1.3 umol/L
Standard Deviation 0.8
|
0.9 umol/L
Standard Deviation 0.7
|
3.2 umol/L
Standard Deviation 1.2
|
|
Discriminative Biomarkers in the Subgroups of Malodor
Butyrate
|
5 umol/L
Standard Deviation 6
|
11 umol/L
Standard Deviation 3
|
6 umol/L
Standard Deviation 6
|
|
Discriminative Biomarkers in the Subgroups of Malodor
2,3-butylene glycol
|
2.6 umol/L
Standard Deviation 1.4
|
1.6 umol/L
Standard Deviation 1.5
|
6.0 umol/L
Standard Deviation 0.0
|
|
Discriminative Biomarkers in the Subgroups of Malodor
Acetate
|
60.6 umol/L
Standard Deviation 16.9
|
68.7 umol/L
Standard Deviation 22.5
|
55.5 umol/L
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Three yearsDisciminative biomarkers for groups of malodor discovered using PCA, compared to control group
Outcome measures
| Measure |
Body Odor
n=7 Participants
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
n=7 Participants
individuals with halitosis, not complaining of body odors
|
"Lactic" Subgroup
n=2 Participants
"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)
|
|---|---|---|---|
|
Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
D lactate, plasma
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
Ethanol, blood
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
Indicans, urine
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
B2 vitamin, blood (EGFR activation)
|
1 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Three yearsThe measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.
Outcome measures
| Measure |
Body Odor
n=7 Participants
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
|
Halitosis
n=7 Participants
individuals with halitosis, not complaining of body odors
|
"Lactic" Subgroup
n=2 Participants
"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)
|
|---|---|---|---|
|
Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor
|
5 grams per day
Standard Deviation 5
|
25 grams per day
Standard Deviation 10
|
20 grams per day
Standard Deviation 10
|
Adverse Events
Body Odor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Halitosis
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