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Exploratory Study of Volatile Organic Compounds in Alveolar Breath

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03451994
Acronym
VOCs
Enrollment
23
Registered
2018-03-02
Start date
2011-10-01
Completion date
2020-10-11
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional and Metabolic Diseases

Brief summary

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

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.

Interventions

OTHERBreath test

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

Sponsors

Menssana Research, Inc.
CollaboratorINDUSTRY
Aurametrix
CollaboratorOTHER
Mebo Research, Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
VOCs detected2 yearsExpired 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

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

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026