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

October 13, 2020 updated by: Mebo Research, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mebo Research, Inc.

Collaborators

Aurametrix
Menssana Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2011

Primary Completion (ACTUAL)

December 31, 2013

Study Completion (ACTUAL)

October 11, 2020

Study Registration Dates

First Submitted

February 18, 2018

First Submitted That Met QC Criteria

February 25, 2018

First Posted (ACTUAL)

March 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20111001005MEBO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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