AzTrials
AzTrials

Nutritional and Metabolic DiseasesNCT02692495

Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis

An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Nutritional and Metabolic Diseases
Type of treatment
Pill or oral medicine
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2009to Feb 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals reporting idiopathic malodor production

Who may be able to join

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

Who cannot join

  • elect not to participate in the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • MeBO Research LTD

    London, England, W10 5LE

Other trials in United Kingdom

About this study

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

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.

Read the 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.
Keywords
body odor, halitosis, dysbiosis, leaky gut, microbiome, PATM, breath odor
Medical subject headings
Nutritional and Metabolic Diseases, Body Odor, Halitosis, Dysbiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02692495
Study groupRoleWhat they receive
Body odorindividuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
Halitosisindividuals with extra-oral halitosis, not complaining of body odors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: four years

Secondary outcomes (3)

  1. 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.

    Measured: three years

  2. 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

    Measured: Three years

  3. 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.

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2013
  4. Study completionFeb 2016

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02692495
Sponsor's protocol ID
200904010001MEBO
Status last verified
Jan 2018
First submitted
16 Feb 2016
Last updated
22 Feb 2018
Data monitoring committee
No
Individual data sharing
Yes: de-identified individual participant data will be made partially available

Publications

  • 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.

    PubMed 873124

  • 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.

    PubMed 7139937

  • 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

  • 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.

    PubMed 19567398

  • 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.

    PubMed 6616831

  • 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.

    PubMed 26429966

  • 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.

    PubMed 17990113

  • 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.

    PubMed 16678553

  • 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.

    PubMed 3827183

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 1 site in United Kingdom.

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 3 inclusion and 1 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Yes. Results are posted in the registry (first posted 24 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Test Results Outside the Normal Range (time frame: four 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 NCT02692495, which also lists 9 linked publications.

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 22 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in