Exploratory Study of Volatile Organic Compounds in Alveolar Breath

Nutritional and Metabolic Diseases Clinical Trial

— VOCs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451994
• Other study ID #: 20111001005MEBO
• Status: Completed
• Start date: October 1, 2011
• Est. completion date: October 11, 2020

Study information

• Verified date: October 2020
• Source: Mebo Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 11, 2020
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	MeBO Research LTD	London	England
United States	MeBO Research	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Mebo Research, Inc.	Aurametrix, Menssana Research, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (1)

Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	1 year