An observational study in Nutritional and Metabolic Diseases, sponsored by Mebo Research, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Mebo Research, Inc. · Observational
This study is designed as a retrospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients self-reporting unexpected and uncontrollable episodes of body odor and/or halitosis. The cohort - generally healthy individuals who had underwent multiple diagnostic tests recommended by their physicians and had not been diagnosed with any known medical condition - expressed their interest in trying gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit. Our retrospective analysis will determine if these tests were useful as potential screening tools for metabolic body odor and halitosis.
Many yet uncharacterized medical conditions including inborn and acquired errors of metabolism or skewed microbiome could be responsible for unpredictable and uncontrollable episodes of body odor and halitosis. These conditions have dramatic impact on the quality of life and socioeconomic outcomes of sufferers. Yet clinics and specialized malodor centers do not provide tests for diagnosing malodor other than trimethylaminuria (TMAU). Self-reported odor problems are often dismissed if are not organoleptically evaluated by trained odor judges that are not readily available during malodor flare-ups.
The aim of this study is to analyze effectiveness of existing gastrointestinal and nutritional tests for the assessment and investigation of self-reported malodors.
Diagnostic tests included:
71 studies on the registry are indexed under Nutritional and Metabolic Diseases; 19 are open to participants now.
This study's enrollment of 16 is below the median of 300 across 17 observational studies indexed under Nutritional and Metabolic Diseases.
Browse Nutritional and Metabolic Diseases studies →Mebo Research, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Individuals reporting idiopathic malodor production
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
individuals with extra-oral halitosis, not complaining of body odors
Number of Test Results Outside the Normal Range
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
Discriminative Biomarkers in the Subgroups of Malodor
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
Number of Test Results Outside the Normal Range in Different Subgroups of Malodor
Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group
Time frame: Three years
Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor
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
| Milestone | Body Odor | Halitosis |
|---|---|---|
| Started | 12 | 4 |
| Completed | 12 | 4 |
| Not completed | 0 | 0 |
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.
| participants | Body Odor | Halitosis |
|---|---|---|
| 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 |
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.
| umol/L | "Sour" Group | "Sweet" Group | "Lactic" Subgroup |
|---|---|---|---|
| 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 |
Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group
| Participants | "Sour" Group | "Sweet" Group | "Lactic" Subgroup |
|---|---|---|---|
| Ethanol, blood | 0 | 7 | 1 |
| Indicans, urine | 1 | 4 | 1 |
| B2 vitamin, blood (EGFR activation) | 1 | 5 | 0 |
| D lactate, plasma | 0 | 0 | 2 |
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.
| grams per day | "Sour" Group | "Sweet" Group | "Lactic" Subgroup |
|---|---|---|---|
| Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor | 5 ± 5 | 25 ± 10 | 20 ± 10 |
Collected over All participants were followed up by email for at least one week after discussing their test results.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Body Odor | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Halitosis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Body Odor | Halitosis | Total |
|---|---|---|---|
| Mean | 30.9 ± 8.5 | 37.5 ± 5.9 | 32.6 ± 8.3 |
| Sex: Female, Male(Participants) | Body Odor | Halitosis | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 9 | 2 | 11 |
| Region of Enrollment(participants) | Body Odor | Halitosis | Total |
|---|---|---|---|
| United Kingdom | 12 | 4 | 16 |
| Duration of condition(years) | Body Odor | Halitosis | Total |
|---|---|---|---|
| Age at onset of symptoms | 21 ± 9 | 29 ± 9 | 23 ± 9 |
| Duration of symptoms | 9 ± 6 | 9 ± 5 | 9 ± 6 |
Plan to share: Yes — de-identified individual participant data will be made partially available
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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