Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

Nutritional and Metabolic Diseases Clinical Trial

Official title:

Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692495
• Other study ID #: 200904010001MEBO
• Status: Completed
• Phase: N/A
• First received: February 16, 2016
• Last updated: January 23, 2018
• Start date: April 2009
• Est. completion date: February 2016

Study information

• Verified date: January 2018
• Source: Mebo Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Halitosis
• Metabolic Diseases
• Nutritional and Metabolic Diseases

Locations

Country	Name	City	State
United Kingdom	MeBO Research LTD	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Mebo Research, Inc.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Chadwick VS, Phillips SF, Hofmann AF. Measurements of intestinal permeability using low molecular weight polyethylene glycols (PEG 400). I. Chemical analysis and biological properties of PEG 400. Gastroenterology. 1977 Aug;73(2):241-6. — View Citation

Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. Review. — View Citation

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

Jenq RR. How's your microbiota? Let's check your urine. Blood. 2015 Oct 1;126(14):1641-2. doi: 10.1182/blood-2015-08-661504. — View Citation

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. Review. — View Citation

Ludvigsen CW, Thurn JR, Pierpont GL, Eckfeldt JH. Kinetic enzymic assay for D(-)-lactate, with use of a centrifugal analyzer. Clin Chem. 1983 Oct;29(10):1823-5. — View Citation

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. — View Citation

Sheedy JR, Wettenhall RE, Scanlon D, Gooley PR, Lewis DP, McGregor N, Stapleton DI, Butt HL, DE Meirleir KL. Increased d-lactic Acid intestinal bacteria in patients with chronic fatigue syndrome. In Vivo. 2009 Jul-Aug;23(4):621-8. — View Citation

Sivakumaran T, Jenkins RT, Walker WH, Goodacre RL. Simplified measurement of polyethylene glycol 400 in urine. Clin Chem. 1982 Dec;28(12):2452-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Discriminative Biomarkers in the Subgroups of Malodor	The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters ("Sour" and "Sweet") shown below along with the "Lactic" subgroup from the "Sour" group.	three years
Secondary	Number of Test Results Outside the Normal Range in Different Subgroups of Malodor	Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group	Three years
Secondary	Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor	The measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.	Three years