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Trial record 1 of 1 for:    NCT03451994
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Exploratory Study of Volatile Organic Compounds in Alveolar Breath (VOCs)

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ClinicalTrials.gov Identifier: NCT03451994
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Menssana Research, Inc.
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

Tracking Information
First Submitted Date February 18, 2018
First Posted Date March 2, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date October 1, 2011
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03451994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 25, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploratory Study of Volatile Organic Compounds in Alveolar Breath
Official Title Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder
Condition 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.
Other Name: Exhaled breath metabolomics
Study Groups/Cohorts
  • Body odor
    individuals self-reporting idiopathic body odor with or without bad breath
    Intervention: Other: Breath test
  • Breath odor
    individuals self-reporting idiopathic bad breath but no body odor
    Intervention: Other: Breath test
Publications * Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 25, 2018)
15
Original Actual Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03451994
Other Study ID Numbers 20111001005MEBO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mebo Research, Inc.
Study Sponsor Mebo Research, Inc.
Collaborators
  • Menssana Research, Inc.
  • Aurametrix
Investigators
Principal Investigator: Irene Gabashvili, PhD MeBO Research
PRS Account Mebo Research, Inc.
Verification Date February 2018