Exploratory Study to Evaluate Potential Screening Tools for yet Uncharacterized Digestive and Metabolic Disorders responsible for body odor or halitosis
This study is currently recruiting participants.         Click to enroll
Verified by the PI
Testing started: April, 2009   Last Updated: June 12, 2010   
Sponsor: MeBO Research;
Research Participants
Collaborators: Biolab Medical Unit;
Aurametrix
San Jose State University
Stanford University
Information provided by: Principal Investigator
ClinicalTrials.gov Identifier: NCT02692495
  Purpose

This study is designed as a prospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients with symptoms of body odor and/or halitosis. We focus on conditions that continue to elude medical diagnosis because known gastrointestinal, metabolic, and endocrine issues associated with odor are not confirmed by laboratory tests, and treatment protocols were not helpful.  Patients self-reporting malodor will be recruited through MeBO  Research sites and virtual support communities to participate in this study. 

BACKGROUND: Certain acquired metabolic inefficiencies can cause a phenomena of strong intermittent body odor or halitosis. Many of such cases can not be linked to trimethylaminuria or any other medically recognized condition. Most sufferers display symptoms similar to irritable bowel syndrome and nutritional imbalances, various skin disorders, some suspect allergy/intolerance to wheat, sugar, diary, peanuts, red meat or other foods. However, even when the sufferers eliminate digestive problems and use antibiotics treatments their odor may persist. Sufferers undergo vigorous medical testing that does not yield any results and are often dismissed by doctors. They are often prescribed antidepressants. The condition has dramatic impact on the socioeconomic status. People either can't keep their jobs, decide to discontinue education or are are on the verge of mental breakdowns due to constant, often indirect, complaints and ridicule from coworkers and customers. 

AIMS: To prove that there is more than anecdotal evidence of the above described condition.  To develop diagnostic procedures that can guide the physician in the diagnosis and treatment.

VOLUNTEERS, COLLABORATORS & FUNDING: : Over 100 sufferers expressed interest in being tested, some of them are able to cover financial expenses associated with testing and even donated to MeBO research to help cover the costs for other participants. UK-based Biolab offered reasonable pricing for diagnostic procedures. We are looking for US, Israel and other labs worldwide interested in working with us and developing novel non-invasive diagnostic procedures. Microbial sequencing and metabolomics analysis of body wapors are planned to be conducted. The PI plans to establish analytical biochemistry lab in San Jose, California and is exploring partnerships with scientific labs worldwide. No commercial interest is involved in the study, although developed diagnostic procedures and software  tools may be commercialized.

 



Condition Intervention Status
Undiagnosed metabolic disorders responsible for strong body odor and/or halitosis

Procedures: Clinical Biochemistry Tests

  • Gut Permeability Profile (using PEG 400 as a probe and measuring all urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall.  (We plan to establish a lab in San Francisco Bay Area and develop a better procedure with the Diamond Choride - Type C silica - column based chromatography and Mass Spec)

 

 

Currently offered (has results)

  • Gut Fermentation Profile (Blood alcohols -  ethanol, methanol, butanol, propanol and short chain fatty acids -  are measured by gas-liquid chromatography). 

 Currently offered (has results)

  • D-lactate test  (D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate)

 Currently offered (may be discontinued)

  • The urine indicans (or 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)

 Currently offered (has results)
  • 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)
 To be replaced with better tests
  • Functional B vitamins profile, focus on Riboflavin (B2) - 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.
 Currently offered
To be replaced with better tests
  • Microbiome Analysis (stool or sweat sample) Affymetrix PhyloChip Platform, 16S rDNA analysis, low coverage (~1000 reads/sample) sequencing using 454 or else
  • Body vapors' metabolomics - longitudinal
 To be offered

Study Type: Exploratory Diagnostic, Observational (Interventional: diagnostic)
Study Design: Allocation: Non-Randomized
Control: Uncontrolled  (due to limited funding)
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Blood and Urine biochemistry in the Diagnosis of Metabolic Disorders associated with strong body odor and halitosis - an Exploratory Study. Evaluating Potential Screening Tools to identify factors that define patients cohorts.

Resource links:

Detailed Description:

Enrollment in diagnostic testing so far: 16. 10 research participants completed testing, partial results for tester #9. Enrollment in questionnaire activities: over 100. Participants are choosing tests based on our priority ranking and their financial capacity.  There also will be additional follow-ups to detail their dietary preferences and medical history.

Quality of life (QOL) questionnaires (such as SNOT20- sinonasal outcome test) are common in medicine, however no such questionnaire exists for body odor and halitosis of metabolic- and digestive origin. Our preliminary pre-testing questionnaire consisted of about 20 questions covering medical history, functional limitation, physical discomfort, psychological discomfort, physical disability and social disability. It was taken by over 100 people. Development of a better questionnaire could assist in correlating subjective body odor and halitosis estimations and their social consequences with results of diagnostic tests.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • systemic body odor or halitosis and no definite diagnosis despite vigorous medical testing
  • age over 18 years
  • both gender
  • informed consent.

Exclusion Criteria:

  • non-compliance
  Contacts and Locations
Contacts
Contact: Irene Gabashvili, PhD
 408-341-WELL Irene-at-Aurametrix.com
MeBO Research Staff  305-724-5107 staff-at-meboresearch.org

 


Locations
Worldwide, samples for most tests can be sent by mail with instructions
Samples should be express-mailed to Biolab within 48 hours


Support Groups


Sponsors and Collaborators
MeBo Research

Biolab Medical Unit, Contact: Mark Howard, Manager
9 Weymouth Street
London
W1W 6DB
Tel:  (+44) 020-7636 5959/5905
Fax: (+44) 020-7580 3910
Internet:  www.biolab.co.uk
E-mail:  mark-at-biolab.co.uk
Investigators
Principal Investigator: Irene Gabashvili, PhD
 Irene.Gabashvili-at-MeboResearch.org

  More Information
Publications by Study Collaborators:

Clinical Chemistry of Malodor Syndromes: Confronting the Elephant in the Room. I.S. Gabashvili, in preparation

Yeast metabolic products, yeast antigens and yeasts as possible triggers for irritable bowel syndrome. Santelmann, H, McLaren Howard, J. .Eur. J. Gastroenterol. Hepatol. 2005; 17(1):21-26 Abstract

Eaton KK, Gaier HC, Howard M, McLaren Howard J, Reid L. Gastric Acid Production, Pancreatic Secretions and Blood Levels of Higher Alcohols in Patients with Fungal-Type Dysbiosis of the Gut. J. Nutr. & Env. Medicine.  2002; 12(2): 107-112. Abstract

Comparison of lactulose breath hydrogen measurements with gut fermentation profiles in patients with fungal-type dysbiosis.  Eaton KK, Chan R, Howard MA, McLaren-Howard JM. J. Nutr. & Env. Med. 2001; 11: 33-42. Abstract

Assessment of Vitamin B1 Status (letter).  McLaren-Howard J. Clinical Chemistry 2000; 46: 11 1867-1868. Letter

Appropriate Testing Nutritional Status. (Abstract) Davies S, McLaren Howard J, Hunnisett A, Howard M. In: Proceedings of Optimal Nutrition for The Family, Australian Council for Responsible Nutrition and The Discipline of Nutrition and Dietetics, University of Newcastle, New South Wales, 25-26 June 1995, Terrigal NSW. Abstract

Gut permeability measured by polyethylene glycol absorption in abnormal gut fermentation as compared with food intolerance. Eaton KK, Howard M, McLaren-Howard J. J. R.Soc.Med 1995;88:63-66 Abstract

 Intestinal Dysbiosis - A Review. McLaren Howard J. Complementary Therapies in Medicine. 1993;1:153-157. Abstract

External Publications Relevant to the Study:

Shimizu M, Cashman JR, Yamazaki H. Transient trimethylaminuria related to menstruation. BMC Med Genet. 2007 Jan 27;8:2.PMID: 17257434 [Full text]

Feller L, Blignaut E. Halitosis: a review. SADJ. 2005 Feb;60(1):17-9. Review.PMID: 15861957

Steinbach S, Reindl W, Kessel C, Ott R, Zahnert T, Hundt W, Heinrich P, Saur D, Huber W. Olfactory and gustatory function in irritable bowel syndrome. Eur Arch Otorhinolaryngol. 2010 Jul;267(7):1081-7. Epub 2009 Dec 30. Jonna Skov Madsen, Mads Nybo, Erik Magid, Jørgen Hilden, Nete Hornung, Torben Bjerregaard Larsen, Lone Jørgensen and Per Erik Jørgensen

More Studies on Outcomes Using Biochemical Diagnostic Tests Are Needed: Findings from the Danish Society of Clinical Biochemistry, Clinical Chemistry 54: 1254-1256, 2008; 10.1373/clinchem.2007.101808
Bruns DE. Laboratory-related outcomes in healthcare. Clin Chem 2001;47:1547-1552.[Abstract/Full Text]
Bossuyt PM, Lijmer JG, Mol BW. Randomised comparison of medical tests: sometimes invalid, not always efficient. Lancet 2000;356:1844-1847.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
Knottnerus JA, Dinant GJ, van Schayck OP. The diagnostic before-after study to assess clinical impact. Knottnerus JA eds. The evidence base of clinical diagnosis 2002 BMJ Books London.
Oosterhuis WP, Bruns DE, Watine J, Sandberg S, Horvath AR. Evidence-based guidelines in laboratory medicine: principles and methods. Clin Chem 2004;50:806-818.[Abstract/Full Text]
Deeks J. Assessing outcomes following tests. Price CP Christenson RH eds. Evidence-based laboratory medicine 2007 AACC Press Washington, DC.
Responsible Party:

MeBO Research

PI: Dr. Irene Gabashvili
ClinicalTrials.gov Identifier: tbd
Other Study ID Numbers:
Study First Received:
Last Updated: June 12, 2010
Health Authority:  

Informed Consent

Support Groups


Keywords provided by MeBO Research:

Body Odor
Halitosis
Malodor Syndrome
Metabolic Body Odor
Metabolic disorder
Digestive disorder

Relevant MeSH terms:
Nutritional and Metabolic Diseases
Digestive System

FAD-monooxygenase
Trimethylamine
Hydrogen Sulfide
Propanols

Selected Results