Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis

Conditions
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Nutritional and Metabolic Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Body odor<br>individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis | |
| Halitosis<br>individuals with extra-oral halitosis, not complaining of body odors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body odor, halitosis, dysbiosis, leaky gut, microbiome, PATM, breath odor