Nutritional and Metabolic Diseases
Conditions
Keywords
body odor, halitosis, dysbiosis, leaky gut, microbiome, PATM, breath odor
Brief summary
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.
Detailed description
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: * Gut Permeability Profile. PEG 400 is used as a probe and measured in urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall. Extraction and separation of PEG from urine is done by ion exchange chromatography and capillary GLC. * Gut Fermentation Profile. Blood alcohols - ethanol, methanol, butanol, propanol and short chain fatty acids - are measured by gas-liquid chromatography. * D-lactate test. D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate * The urine indicans (Obermeyer) test. Detection of indican in the urine depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer * Breath test for small intestinal dysbiosis. Breath hydrogen and methane are measured by gas-liquid chromatography. The patient is given 10 gm of lactulose in 200 ml of water and alveolar air samples are collected every 20 minutes for 3 hours * Functional B vitamins profile, by measuring the activation of a red cell enzyme that is dependent upon an adequate concentration of a particular vitamin for full activity. The assay relies on normal metabolism of the vitamin to its native form and the presence of other non-vitamin cofactors.
Interventions
None listed
Sponsors
Mebo Research, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* idiopathic malodor experienced over a period of several months or years * willing and able to complete the study * good general health
Exclusion criteria
* elect not to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Test Results Outside the Normal Range | four years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discriminative Biomarkers in the Subgroups of Malodor | three years | 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. |
| Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Three years | Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group |
| Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor | Three years | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Body Odor individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis | 12 |
| Halitosis individuals with halitosis, not complaining of body odors | 4 |
| Total | 16 |
Baseline characteristics
| Characteristic | Halitosis | Total | Body Odor |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 5.9 | 32.6 years STANDARD_DEVIATION 8.3 | 30.9 years STANDARD_DEVIATION 8.5 |
| Duration of condition Age at onset of symptoms | 29 years STANDARD_DEVIATION 9 | 23 years STANDARD_DEVIATION 9 | 21 years STANDARD_DEVIATION 9 |
| Duration of condition Duration of symptoms | 9 years STANDARD_DEVIATION 5 | 9 years STANDARD_DEVIATION 6 | 9 years STANDARD_DEVIATION 6 |
| Region of Enrollment United Kingdom | 4 participants | 16 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 4 |
| other Total, other adverse events | 0 / 12 | 0 / 4 |
| serious Total, serious adverse events | 0 / 12 | 0 / 4 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2,3-butylene glycol | 4 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 1-butanol | 1 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Increased blood acetate | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 1-propanol | 8 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Decreased blood acetate | 4 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-butanol | 2 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Decreased blood propionate | 4 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-methyl-1-propanol | 6 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Decreased blood butyrate | 5 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-methyl-1-butanol | 6 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Blood Succinate out of range | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated blood methanol | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Blood Valerate out of range | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-methyl-2-butanol | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Increased gut permeability | 9 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-methyl-2-propanol | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Decreased gut permeability | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-ethyl-1-butanol | 0 participants |
| Body Odor | Number of Test Results Outside the Normal Range | increased blood D-lactate | 3 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated 2-propanol | 3 participants |
| Body Odor | Number of Test Results Outside the Normal Range | increased urine Indicans | 5 participants |
| Body Odor | Number of Test Results Outside the Normal Range | Elevated blood ethanol | 6 participants |
| Halitosis | Number of Test Results Outside the Normal Range | increased urine Indicans | 1 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated blood ethanol | 3 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated blood methanol | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 1-propanol | 3 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-propanol | 3 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-methyl-1-propanol | 2 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-methyl-2-propanol | 1 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 1-butanol | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-butanol | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-methyl-1-butanol | 1 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-methyl-2-butanol | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2-ethyl-1-butanol | 1 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Elevated 2,3-butylene glycol | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Increased blood acetate | 1 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Decreased blood acetate | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Decreased blood propionate | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Decreased blood butyrate | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Blood Succinate out of range | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Blood Valerate out of range | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Increased gut permeability | 0 participants |
| Halitosis | Number of Test Results Outside the Normal Range | Decreased gut permeability | 2 participants |
| Halitosis | Number of Test Results Outside the Normal Range | increased blood D-lactate | 0 participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Body Odor | Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor | 5 grams per day | Standard Deviation 5 |
| Halitosis | Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor | 25 grams per day | Standard Deviation 10 |
| Lactic Subgroup | Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor | 20 grams per day | Standard Deviation 10 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Body Odor | Discriminative Biomarkers in the Subgroups of Malodor | 2,3-butylene glycol | 2.6 umol/L | Standard Deviation 1.4 |
| Body Odor | Discriminative Biomarkers in the Subgroups of Malodor | Butyrate | 5 umol/L | Standard Deviation 6 |
| Body Odor | Discriminative Biomarkers in the Subgroups of Malodor | D-lactate | 7 umol/L | Standard Deviation 5 |
| Body Odor | Discriminative Biomarkers in the Subgroups of Malodor | 2- butanol | 1.3 umol/L | Standard Deviation 0.8 |
| Body Odor | Discriminative Biomarkers in the Subgroups of Malodor | Acetate | 60.6 umol/L | Standard Deviation 16.9 |
| Halitosis | Discriminative Biomarkers in the Subgroups of Malodor | Butyrate | 11 umol/L | Standard Deviation 3 |
| Halitosis | Discriminative Biomarkers in the Subgroups of Malodor | D-lactate | 29 umol/L | Standard Deviation 39 |
| Halitosis | Discriminative Biomarkers in the Subgroups of Malodor | 2- butanol | 0.9 umol/L | Standard Deviation 0.7 |
| Halitosis | Discriminative Biomarkers in the Subgroups of Malodor | 2,3-butylene glycol | 1.6 umol/L | Standard Deviation 1.5 |
| Halitosis | Discriminative Biomarkers in the Subgroups of Malodor | Acetate | 68.7 umol/L | Standard Deviation 22.5 |
| Lactic Subgroup | Discriminative Biomarkers in the Subgroups of Malodor | Acetate | 55.5 umol/L | Standard Deviation 37.5 |
| Lactic Subgroup | Discriminative Biomarkers in the Subgroups of Malodor | 2,3-butylene glycol | 6.0 umol/L | Standard Deviation 0 |
| Lactic Subgroup | Discriminative Biomarkers in the Subgroups of Malodor | D-lactate | 330 umol/L | Standard Deviation 245 |
| Lactic Subgroup | Discriminative Biomarkers in the Subgroups of Malodor | Butyrate | 6 umol/L | Standard Deviation 6 |
| Lactic Subgroup | Discriminative Biomarkers in the Subgroups of Malodor | 2- butanol | 3.2 umol/L | Standard Deviation 1.2 |
p-value: <0.01t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Body Odor | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | B2 vitamin, blood (EGFR activation) | 1 Participants |
| Body Odor | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Indicans, urine | 1 Participants |
| Body Odor | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Ethanol, blood | 0 Participants |
| Body Odor | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | D lactate, plasma | 0 Participants |
| Halitosis | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Indicans, urine | 4 Participants |
| Halitosis | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | D lactate, plasma | 0 Participants |
| Halitosis | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Ethanol, blood | 7 Participants |
| Halitosis | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | B2 vitamin, blood (EGFR activation) | 5 Participants |
| Lactic Subgroup | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Ethanol, blood | 1 Participants |
| Lactic Subgroup | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | D lactate, plasma | 2 Participants |
| Lactic Subgroup | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | B2 vitamin, blood (EGFR activation) | 0 Participants |
| Lactic Subgroup | Number of Test Results Outside the Normal Range in Different Subgroups of Malodor | Indicans, urine | 1 Participants |