Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

NCT02692495 | Completed Results

• 1 other identifier: 200904010001MEBO
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a retrospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients self-reporting unexpected and uncontrollable episodes of body odor and/or halitosis. The cohort - generally healthy individuals who had underwent multiple diagnostic tests recommended by their physicians and had not been diagnosed with any known medical condition - expressed their interest in trying gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit. Our retrospective analysis will determine if these tests were useful as potential screening tools for metabolic body odor and halitosis.

Conditions

Nutritional and Metabolic Diseases

Keywords

body odor; halitosis; dysbiosis; leaky gut; microbiome; PATM; breath odor

Outcome Measures

Primary Outcomes (1)

• Number of Test Results Outside the Normal Range

  The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.

  four years

Secondary Outcomes (3)

• Discriminative Biomarkers in the Subgroups of Malodor

  three years

• Number of Test Results Outside the Normal Range in Different Subgroups of Malodor

  Three years

• Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor

  Three years

Study Arms (2)

Body odor

individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis

Halitosis

individuals with extra-oral halitosis, not complaining of body odors

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals reporting idiopathic malodor production

You may qualify if:

• idiopathic malodor experienced over a period of several months or years
• willing and able to complete the study
• good general health

You may not qualify if:

• elect not to participate in the study

Sponsors & Collaborators

• Mebo Research, Inc.: lead

Study Sites (1)

MeBO Research LTD

London, England, W10 5LE, United Kingdom

Location

Related Publications (9)

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  BACKGROUND

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  PMID: 17990113 BACKGROUND

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  PMID: 16678553 BACKGROUND

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  PMID: 3827183 BACKGROUND

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Body Odor; Halitosis; Dysbiosis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pathologic Processes

Results Point of Contact

• Title: Irene Gabashvili, Scientific Director
• Organization: MEBO Research

irene.gabashvili@meboresearch.org

(408) 341-9355

Study Officials

• Irene Gabashvili, PhD

  MeBO Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 26, 2016
• Study Start: April 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2016
• Last Updated: February 22, 2018
• Results First Posted: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)