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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.

Tracking Information
First Submitted Date February 16, 2016
First Posted Date February 26, 2016
Results First Submitted Date March 8, 2016
Results First Posted Date January 24, 2018
Last Update Posted Date February 22, 2018
Study Start Date April 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2017)
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.
Original Primary Outcome Measures
 (submitted: February 22, 2016)
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.
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2018)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: February 22, 2016)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis
Official Title Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals reporting idiopathic malodor production
Condition Nutritional and Metabolic Diseases
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2017)
16
Original Actual Enrollment
 (submitted: February 22, 2016)
15
Actual Study Completion Date February 2016
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02692495
Other Study ID Numbers 200904010001MEBO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: de-identified individual participant data will be made partially available
Responsible Party Mebo Research, Inc.
Study Sponsor Mebo Research, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Irene Gabashvili, PhD MeBO Research
PRS Account Mebo Research, Inc.
Verification Date January 2018