Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

NCT ID: NCT02692495

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2016-02-29

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.

Detailed Description

Many yet uncharacterized medical conditions including inborn and acquired errors of metabolism or skewed microbiome could be responsible for unpredictable and uncontrollable episodes of body odor and halitosis. These conditions have dramatic impact on the quality of life and socioeconomic outcomes of sufferers. Yet clinics and specialized malodor centers do not provide tests for diagnosing malodor other than trimethylaminuria (TMAU). Self-reported odor problems are often dismissed if are not organoleptically evaluated by trained odor judges that are not readily available during malodor flare-ups.

The aim of this study is to analyze effectiveness of existing gastrointestinal and nutritional tests for the assessment and investigation of self-reported malodors.

Diagnostic tests included:

• Gut Permeability Profile. PEG 400 is used as a probe and measured in urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall. Extraction and separation of PEG from urine is done by ion exchange chromatography and capillary GLC.
• Gut Fermentation Profile. Blood alcohols - ethanol, methanol, butanol, propanol and short chain fatty acids - are measured by gas-liquid chromatography.
• D-lactate test. D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate
• The urine indicans (Obermeyer) test. Detection of indican in the urine depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer
• Breath test for small intestinal dysbiosis. Breath hydrogen and methane are measured by gas-liquid chromatography. The patient is given 10 gm of lactulose in 200 ml of water and alveolar air samples are collected every 20 minutes for 3 hours
• Functional B vitamins profile, by measuring the activation of a red cell enzyme that is dependent upon an adequate concentration of a particular vitamin for full activity. The assay relies on normal metabolism of the vitamin to its native form and the presence of other non-vitamin cofactors.

Conditions

Nutritional and Metabolic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Body odor

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

No interventions assigned to this group

Halitosis

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• elect not to participate in the study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mebo Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Gabashvili, PhD

Role: PRINCIPAL_INVESTIGATOR

MeBO Research

Locations

MeBO Research LTD

London, England, United Kingdom

Countries

United Kingdom

References

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Reference Type: BACKGROUND

PMID: 873124 (View on PubMed)

Sivakumaran T, Jenkins RT, Walker WH, Goodacre RL. Simplified measurement of polyethylene glycol 400 in urine. Clin Chem. 1982 Dec;28(12):2452-3. No abstract available.

Reference Type: BACKGROUND

PMID: 7139937 (View on PubMed)

Hunnisett A., Howard J., Davies S. Gut fermentation (or the 'Auto-brewery') Syndrome: A new clinical test with initial observations and discussion of clinical and biochemical implications J.Nutr.Med.1:33-8, 1990

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 6616831 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26429966 (View on PubMed)

Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.

Reference Type: BACKGROUND

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Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

Reference Type: BACKGROUND

PMID: 16678553 (View on PubMed)

Mount JN, Heduan E, Herd C, Jupp R, Kearney E, Marsh A. Adaptation of coenzyme stimulation assays for the nutritional assessment of vitamins B1, B2 and B6 using the Cobas Bio centrifugal analyser. Ann Clin Biochem. 1987 Jan;24 ( Pt 1):41-6. doi: 10.1177/000456328702400106.

Reference Type: BACKGROUND

PMID: 3827183 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Other Identifiers

200904010001MEBO

Identifier Type: -

Identifier Source: org_study_id