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Completed

NCT Number: NCT03451994

Exploratory Study of Volatile Organic Compounds in Alveolar Breath

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

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Key information

Conditions

Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MeBO Research LTD, London, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath Test

Other

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

Other names: Exhaled breath metabolomics

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mebo Research, Inc.

Other

Collaborators

  • Aurametrix
  • Menssana Research, Inc.

Registry information

Official study title

Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor

Acronym: VOCs

Important dates

Study start
2011
Primary completion
2013
Study completion
2020
First posted
Mar 2, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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