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Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

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ClinicalTrials.gov Identifier: NCT02692495
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : January 24, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mebo Research, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Nutritional and Metabolic Diseases
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Body Odor Halitosis
Hide Arm/Group Description individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis individuals with halitosis (bad breath), not complaining of body odors
Period Title: Overall Study
Started 12 4
Completed 12 4
Not Completed 0 0
Arm/Group Title Body Odor Halitosis Total
Hide Arm/Group Description individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis individuals with halitosis, not complaining of body odors Total of all reporting groups
Overall Number of Baseline Participants 12 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 16 participants
30.9  (8.5) 37.5  (5.9) 32.6  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 16 participants
Female
3
  25.0%
2
  50.0%
5
  31.3%
Male
9
  75.0%
2
  50.0%
11
  68.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 12 participants 4 participants 16 participants
12 4 16
Duration of condition  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 16 participants
Age at onset of symptoms 21  (9) 29  (9) 23  (9)
Duration of symptoms 9  (6) 9  (5) 9  (6)
1.Primary Outcome
Title Number of Test Results Outside the Normal Range
Hide Description 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.
Time Frame four years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Body Odor Halitosis
Hide Arm/Group Description:
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
individuals with halitosis, not complaining of body odors
Overall Number of Participants Analyzed 12 4
Measure Type: Number
Unit of Measure: participants
Elevated blood ethanol 6 3
Elevated blood methanol 0 0
Elevated 1-propanol 8 3
Elevated 2-propanol 3 3
Elevated 2-methyl-1-propanol 6 2
Elevated 2-methyl-2-propanol 0 1
Elevated 1-butanol 1 0
Elevated 2-butanol 2 0
Elevated 2-methyl-1-butanol 6 1
Elevated 2-methyl-2-butanol 0 0
Elevated 2-ethyl-1-butanol 0 1
Elevated 2,3-butylene glycol 4 0
Increased blood acetate 0 1
Decreased blood acetate 4 0
Decreased blood propionate 4 0
Decreased blood butyrate 5 0
Blood Succinate out of range 0 0
Blood Valerate out of range 0 0
Increased gut permeability 9 0
Decreased gut permeability 0 2
increased blood D-lactate 3 0
increased urine Indicans 5 1
2.Secondary Outcome
Title Discriminative Biomarkers in the Subgroups of Malodor
Hide Description The 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.
Time Frame three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Sour" Group "Sweet" Group "Lactic" Subgroup
Hide Arm/Group Description:
Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)
Overall Number of Participants Analyzed 7 7 2
Mean (Standard Deviation)
Unit of Measure: umol/L
D-lactate 7  (5) 29  (39) 330  (245)
2- butanol 1.3  (0.8) 0.9  (0.7) 3.2  (1.2)
Butyrate 5  (6) 11  (3) 6  (6)
2,3-butylene glycol 2.6  (1.4) 1.6  (1.5) 6.0  (0.0)
Acetate 60.6  (16.9) 68.7  (22.5) 55.5  (37.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection "Sour" Group, "Sweet" Group, "Lactic" Subgroup
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
Hide Description Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group
Time Frame Three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Sour" Group "Sweet" Group "Lactic" Subgroup
Hide Arm/Group Description:
Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
"Garbage" odor identified as one of the most common types of odor
Overall Number of Participants Analyzed 7 7 2
Measure Type: Count of Participants
Unit of Measure: Participants
Ethanol, blood
0
   0.0%
7
 100.0%
1
  50.0%
Indicans, urine
1
  14.3%
4
  57.1%
1
  50.0%
B2 vitamin, blood (EGFR activation)
1
  14.3%
5
  71.4%
0
   0.0%
D lactate, plasma
0
   0.0%
0
   0.0%
2
 100.0%
4.Secondary Outcome
Title Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor
Hide Description The 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.
Time Frame Three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Sour" Group "Sweet" Group "Lactic" Subgroup
Hide Arm/Group Description:
Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
"Garbage" odor identified as one of the most common types of odor
Overall Number of Participants Analyzed 7 7 2
Mean (Standard Deviation)
Unit of Measure: grams per day
5  (5) 25  (10) 20  (10)
Time Frame All participants were followed up by email for at least one week after discussing their test results.
Adverse Event Reporting Description

Adverse effects were defined as any events, expected or not, that affected participant well being, regardless of whether there was a causal relationship with the diagnostic testing and discussion of the results.

Serious adverse events were defined as those that prevented a participant from performing normal activities and required treatment.

 
Arm/Group Title Body Odor Halitosis
Hide Arm/Group Description individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis individuals self-reporting breath malodors but not body odors
All-Cause Mortality
Body Odor Halitosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Body Odor Halitosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Body Odor Halitosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Irene Gabashvili, Scientific Director
Organization: MEBO Research
Phone: (408) 341-9355
EMail: irene.gabashvili@meboresearch.org
Publications:
Hunnisett A., Howard J., Davies S. Gut fermentation (or the 'Auto-brewery') Syndrome: A new clinical test with initial observations and discussion of clinical and biochemical implications J.Nutr.Med.1:33-8, 1990
Layout table for additonal information
Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02692495    
Other Study ID Numbers: 200904010001MEBO
First Submitted: February 16, 2016
First Posted: February 26, 2016
Results First Submitted: March 8, 2016
Results First Posted: January 24, 2018
Last Update Posted: February 22, 2018