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Exploratory Study of Volatile Organic Compounds in Alveolar Breath (VOCs)

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ClinicalTrials.gov Identifier: NCT03451994
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
Menssana Research, Inc.
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

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

Condition or disease Intervention/treatment
Nutritional and Metabolic Diseases 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 Type : Observational
Actual Enrollment : 15 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 : October 1, 2011
Actual Primary Completion Date : December 31, 2013
Estimated Study Completion Date : December 1, 2018

Group/Cohort 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 Name: 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 Name: Exhaled breath metabolomics




Primary Outcome Measures :
  1. VOCs detected [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder
Criteria

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

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): NCT03451994


Locations
United States, Florida
MeBO Research
Miami, Florida, United States, 33175
United Kingdom
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

Publications:
Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT03451994     History of Changes
Other Study ID Numbers: 20111001005MEBO
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Metabolic Diseases