Nutritional and Metabolic DiseasesVOCsNCT03451994
Exploratory Study of Volatile Organic Compounds in Alveolar Breath
An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- Breath test
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2011to 11 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder
Who may be able to join
- good general health
- willing and able to travel to one of the participating sites
Who cannot join
- medical conditions that, in the opinion of the investigator, would prevent participation
- elect not to participate in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- Breath test
- Medical subject headings
- Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testOther
Also called Exhaled breath metabolomics
Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.
| Study group | Role | What they receive |
|---|---|---|
| Body odor | individuals self-reporting idiopathic body odor with or without bad breath Receives: Other: Breath test | |
| Breath odor | individuals self-reporting idiopathic bad breath but no body odor Receives: Other: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Oct 2011
- Primary completion31 Dec 2013
- Study completion11 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mebo Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Menssana Research, Inc., Aurametrix
- Responsible party
- Sponsor
- Investigators
- Irene Gabashvili, PhD, Principal investigator, MeBO Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451994
- Sponsor's protocol ID
- 20111001005MEBO
- Acronym
- VOCs
- Status last verified
- Oct 2020
- First submitted
- 18 Feb 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069.
PubMed 9177688
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor
- ClinicalTrials.gov ID
- NCT03451994
- Acronym / sponsor ID
- VOCs / 20111001005MEBO
- Conditions
- Nutritional and Metabolic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mebo Research, Inc.University, hospital or other
- Collaborators
- Menssana Research, Inc., Aurametrix
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 11 Oct 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body odor | – | Other: Breath testindividuals self-reporting idiopathic body odor with or without bad breath |
| Breath odor | – | Other: Breath testindividuals self-reporting idiopathic bad breath but no body odor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder
Key inclusion criteria (2 listed)
- good general health
- willing and able to travel to one of the participating sites
Key exclusion criteria (2 listed)
- medical conditions that, in the opinion of the investigator, would prevent participation
- elect not to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath testAlso: Exhaled breath metabolomicsBreath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given. | Other | Body odor, Breath odor |
Primary outcome
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.
1 secondary outcome
Correlations between breath biomarkers and self-reported observations (questionnaires)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 9177688Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Gabashvili, PhD principal investigator
MeBO Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOCs detected (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.