NCT03451994

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

February 18, 2018

Last Update Submit

October 13, 2020

Conditions

Nutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlations between breath biomarkers and self-reported observations (questionnaires)

    1 year

Study Arms (2)

Body odor

individuals self-reporting idiopathic body odor with or without bad breath

Other: Breath test

Breath odor

individuals self-reporting idiopathic bad breath but no body odor

Other: Breath test

Interventions

Breath testOTHER

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

Also known as: Exhaled breath metabolomics
Body odorBreath odor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder

You may qualify if:

  • good general health
  • willing and able to travel to one of the participating sites

You may not qualify if:

  • medical conditions that, in the opinion of the investigator, would prevent participation
  • elect not to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MeBO Research

Miami, Florida, 33175, United States

Location

MeBO Research LTD

London, England, W10 5LE, United Kingdom

Location

Related 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. doi: 10.1006/abio.1997.2069.

    PMID: 9177688BACKGROUND

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Officials

  • Irene Gabashvili, PhD

    MeBO Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2018

First Posted

March 2, 2018

Study Start

October 1, 2011

Primary Completion

December 31, 2013

Study Completion

October 11, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

US(1)GB(1)