Exploratory Study of Volatile Organic Compounds in Alveolar Breath

Completed

• Conditions: Nutritional and Metabolic Diseases
• Interventions: Other: Breath test

• Registration Number: NCT03451994
• Lead Sponsor: Mebo Research, Inc.

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.

Study Timeline

• Study Start: 2011-10-01
• Primary Completion: 2013-12-31
• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-03-02
• Status Verified: 2020-10
• Study Completion: 2020-10-11
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breath odor	Breath test	individuals self-reporting idiopathic bad breath but no body odor
Body odor	Breath test	individuals self-reporting idiopathic body odor with or without bad breath

Primary Outcome Measures

Name	Time	Method
VOCs detected	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 Outcome Measures

Name	Time	Method
Correlations between breath biomarkers and self-reported observations (questionnaires)	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.

Trial Locations

Locations (2)

MeBO Research; 🇺🇸 Miami, Florida, United States

MeBO Research LTD; 🇬🇧 London, England, United Kingdom