Microbial Basis of Systemic Malodor and People Allergic To Me Conditions

Study Overview
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Brief Summary
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The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.

Detailed Description
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Human odorprints, mostly owing to the microbiome, have proven their value as biomarkers of health and environmental exposures. In recent years, microbial networks responsible for localized malodors such as halitosis or axillary odor have been mapped by using next generation sequencing approaches. Intestinal microbes responsible for psychologically debilitating systemic malodor (whole-body and extraoral halitosis), however, remain to be identified. Even a relatively straightforward disorder of choline metabolism trimethylaminuria (TMAU) is thought to exhibit complex host-gene microbiome interactions and has not been sufficiently studied. Proposed controlled pilot study aims to explore the dynamics of microbial communities in remission and flare-up periods. Better knowledge of the important aspects of disease fluctuation should enhance patient care and, combined with our prior data, will help to develop new therapies and treatments.

Official Title
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Dynamics of the Gut Microbiota in Idiopathic Malodor Production

Conditions
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Nutritional and Metabolic Diseases

Intervention / Treatment
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* Behavioral: Nutritional counselling
* Behavioral: Stress-reduction counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: idiopathic malodor or PATM symptoms experienced over a period of several months or years able to read and understand the study information willing and able to comply with questionnaires, nutritional recommendations, and other study procedures Exclusion Criteria: consistent inability to communicate and process things related to their symptoms consistent inability to distinguish physical symptoms from pure emotional reactions lack of motivation to start feeling better

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEBO/PATM cohort<br>Nutrition counselling and stress-management counselling behavioral interventions will be given to minimize subjects symptoms and observe corresponding changes in their microbiomes. The following subcohorts were formed for analyses of different outcomes: MEBO and PATM subcohorts, TMAU positive and negative subcohorts, Active MEBO, Active PATM, Regression and Remission; MEBO/PATM Cohort that Submitted Gut Samples, MEBO/PATM cohort that answered QoL survey, MEBO/PATM Subcohort that observed and documented both flareups and improvements. | Behavioral: Nutritional counselling<br>* Behavioral nutritional counselling delivered via the Internet.<br>Behavioral: Stress-reduction counseling<br>* The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.<br>|
| No Intervention: non-MEBO cohort<br>Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiome | Abundance [operational taxonomic units] | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life [Score] | QoL: Scores range from 20 (lowest level of satisfaction with life) to 150 (maximal life satisfaction). Quality of life (QOL) will be measured with MEBO quality of life assessment questionnaire, a new tool designed on the basis of the Halitosis Associated Life-quality Test (HALT), Dermatology Life Quality Index (DLQI) and WHOQOL-100 questionnaires. Most questions were devised with a Likert scale of 0-5 where a higher score indicated a higher quality of life. Scores for five negatively framed questions are transformed to positively framed questions. Total QOL score (minimum score of 20 and maximum score of 150) is computed based on four aspects of QOL: physical health, psychological health, social support and environment. | 1 year | 
| Idiopathic Malodor Episodes | The number of flareups after study enrollment | 1 year after study enrollment | 
| Change in Fecal Microbiome Composition Between Flare-ups and Improvements | The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples | 1 year | 
| Alpha Diversity | Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic malodor, body odor, bad breath, PATM, microbiome, TMAU, Malabsorption, Dysbiosis