|Sponsor:|| MeBO Research;
Biolab Medical Unit;
San Jose State University
|Information provided by:||Principal Investigator
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
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.
|Undiagnosed metabolic disorders responsible for strong body odor and/or halitosis||
Procedures: Clinical Biochemistry Tests
Currently offered (has results)
||Currently offered (has results)|
||Currently offered (may be discontinued)|
||Currently offered (has results)|
||To be replaced with better tests|
|To be replaced with better tests|
||To be offered|
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.
NLM Reference: Metabolic Disorders, Irritable Bowel Syndrome, Celiac Disease , Lactose Intolerance, Malnutrition, Nutrition, Food Allergy, Breath odor,
Genetics Home Reference related topics: , FMO3 gene summary, trimethylaminuria condition summary, tyrosinemia condition summary, ..
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.
|Contact: Irene Gabashvili, PhD
|MeBO Research Staff||305-724-5107||staff-at-meboresearch.org
|Worldwide, samples for most tests can be sent by mail with instructions
Samples should be express-mailed to Biolab within 48 hours
9 Weymouth Street
Tel: (+44) 020-7636 5959/5905
Fax: (+44) 020-7580 3910
|Principal Investigator:||Irene Gabashvili, PhD
Publications by Study Collaborators:
Clinical Chemistry of Malodor Syndromes: Confronting the Elephant in the Room. I.S. Gabashvili, in preparation
metabolic products, yeast antigens and yeasts as possible triggers for
bowel syndrome. Santelmann, H, McLaren Howard, J. .Eur. J.
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
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.
PI: Dr. Irene Gabashvili
|Other Study ID Numbers:|
|Study First Received:|
|Last Updated:||June 12, 2010|
Keywords provided by MeBO Research:
Relevant MeSH terms:
Nutritional and Metabolic Diseases