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CompletedNCT03451994VOCsUpdated Oct 14, 2020

Exploratory Study of Volatile Organic Compounds in Alveolar Breath

An observational study in Nutritional and Metabolic Diseases, sponsored by Mebo Research, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Mebo Research, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Nutritional and Metabolic Diseases

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

  • good general health
  • willing and able to travel to one of the participating sites

Exclusion criteria

Exclusion Criteria:

  • medical conditions that, in the opinion of the investigator, would prevent participation
  • elect not to participate in the study
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • Body odor

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

    Other: Breath test

  • Breath odor

    individuals self-reporting idiopathic bad breath but no body odor

    Other: Breath test

Interventions

  • OtherBreath test

    Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.

    Also known as: Exhaled breath metabolomics

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What researchers measure

Primary outcomes

  1. VOCs detected

    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.

    Time frame: 2 years

Secondary outcomes

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

    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.

    Time frame: 1 year

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Study locations

2 sites
  • MeBO Research
    Miami, Florida 33175, United States
  • MeBO Research LTD
    London, England W10 5LE, United Kingdom
07

References and documents

Publications

  • Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069. PubMed 9177688 ↗
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Registry details

Key details

Study ID
NCT03451994
Lead sponsor
Mebo Research, Inc.
Collaborators
Menssana Research, Inc., Aurametrix
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Oct 1, 2011
Primary completion
Dec 31, 2013
Completion
Oct 11, 2020
Last update
Oct 14, 2020

Study contacts

Irene Gabashvili, PhD
principal investigator · MeBO Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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