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Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02692495
First Posted: February 26, 2016
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Mebo Research, Inc.
  Purpose
This study is designed as a prospective 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. Our initial cohort is generally healthy individuals who already underwent multiple diagnostic tests recommended by their physicians and have not been diagnosed with any known condition. The investigators will analyze results of gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit to determine if these tests are useful as potential screening tools for metabolic body odor and halitosis.

Condition
Nutritional and Metabolic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis

Resource links provided by NLM:


Further study details as provided by Mebo Research, Inc.:

Primary Outcome Measures:
  • Number of test results outside the normal range [ Time Frame: four years ]
    The investigators would like to validate if diagnostic tests taken by participants (see the list in the detailed description of the study) can be used for diagnosing malodor. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.


Secondary Outcome Measures:
  • Identification of sensitive and specific biomarkers that correlate with subjective reports of malodor symptoms (questionnaires) [ Time Frame: three years ]
    The investigators will comprehensively analyze diagnostic ability of tests taken by participants to correlate with their symptoms and discriminate between different subgroups of malodor.


Enrollment: 15
Study Start Date: April 2009
Study Completion Date: February 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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 include:

  • 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.
  Eligibility

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
United Kingdom
MeBO Research LTD
London, England, United Kingdom, W10 5LE
Sponsors and Collaborators
Mebo Research, Inc.
Investigators
Principal Investigator: Irene Gabashvili, PhD MeBO Research
  More Information

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

Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT02692495     History of Changes
Other Study ID Numbers: 200904010001MEBO
First Submitted: February 16, 2016
First Posted: February 26, 2016
Last Update Posted: October 12, 2017
Last Verified: February 2016
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

Additional relevant MeSH terms:
Metabolic Diseases
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms