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Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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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.

Condition or disease
Nutritional and Metabolic Diseases

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.
Study Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis
Study Start Date : April 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath

Groups and Cohorts
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Group/Cohort
Body odor
individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
Halitosis
individuals with extra-oral halitosis, not complaining of body odors


Outcome Measures
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Primary Outcome Measures :
  1. Number of Test Results Outside the Normal Range [ Time Frame: 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 Outcome Measures :
  1. Discriminative Biomarkers in the Subgroups of Malodor [ Time Frame: 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.

  2. Number of Test Results Outside the Normal Range in Different Subgroups of Malodor [ Time Frame: Three years ]
    Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group

  3. Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals reporting idiopathic malodor production
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692495


Locations
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United Kingdom
MeBO Research LTD
London, England, United Kingdom, W10 5LE
Sponsors and Collaborators
Mebo Research, Inc.
Investigators
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Principal Investigator: Irene Gabashvili, PhD MeBO Research
More Information
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Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 10.17632/8bk6h6bmkr.1
Clinical Study Report  This link exits the ClinicalTrials.gov site
Preprint  This link exits the ClinicalTrials.gov site
Identifier: 10.1101/139014
Study results

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

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Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02692495    
Other Study ID Numbers: 200904010001MEBO
First Posted: February 26, 2016    Key Record Dates
Results First Posted: January 24, 2018
Last Update Posted: February 22, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified individual participant data will be made partially available
Keywords provided by Mebo Research, Inc.:
body odor
halitosis
dysbiosis
leaky gut
 microbiome
PATM
breath odor
Additional relevant MeSH terms:
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Metabolic Diseases
Halitosis
Body Odor
Signs and Symptoms, Digestive