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VOCs: Exploratory Study of Volatile Organic Compounds in Alveolar Breath

Sponsor
Mebo Research, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03451994
Collaborator
Menssana Research, Inc. (Industry), Aurametrix (Other)
23
Enrollment
2
Locations
108.4
Actual Duration (Months)
11.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

Condition or Disease Intervention/Treatment Phase
  • Other: Breath test

Detailed Description

Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor
Actual Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Dec 31, 2013
Actual Study Completion Date :
Oct 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Body odor

individuals self-reporting idiopathic body odor with or without bad breath

Other: Breath test
Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.
Other Names:
  • Exhaled breath metabolomics

    		•
    Breath odor

    individuals self-reporting idiopathic bad breath but no body odor

    Other: Breath test
    Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.
    Other Names:
  • Exhaled breath metabolomics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VOCs detected [2 years]

      Expired air sample drawn principally from alveolar breath is analyzed by gas chromatography-mass spectrometry. Chromatograms are searched against the NIST library. The response for each analyte is normalized by using internal standards containing 1-bromo-4-fluoro-benzene.

    Secondary Outcome Measures

    1. Correlations between breath biomarkers and self-reported observations (questionnaires) [1 year]

      VOC profiles will be compared with self-reported symptoms, observed exposures and other observations of participating subjects. Volatile organic compounds differentiating the disease activity will be identified.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • good general health

    • willing and able to travel to one of the participating sites

    Exclusion Criteria:

    • medical conditions that, in the opinion of the investigator, would prevent participation

    • elect not to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MeBO Research Miami Florida United States 33175
    2 MeBO Research LTD London England United Kingdom W10 5LE

    Sponsors and Collaborators

    • Mebo Research, Inc.
    • Menssana Research, Inc.
    • Aurametrix

    Investigators

    • Principal Investigator: Irene Gabashvili, PhD, MeBO Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mebo Research, Inc.
    ClinicalTrials.gov Identifier:
    NCT03451994
    Other Study ID Numbers:
    • 20111001005MEBO
    First Posted:
    Mar 2, 2018
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metabolic Diseases

    Study Results

    No Results Posted as of Oct 14, 2020