Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions (PATM)

Dynamics of the Gut Microbiota in Idiopathic Malodor Production

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

Study Overview

• Status: Completed
• Conditions: Nutritional and Metabolic Diseases
• Intervention / Treatment: Behavioral: Nutritional counselling; Behavioral: Stress-reduction counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, W10 5LE
      • MeBO Research LTD
• United States
  • Florida
    • Miami, Florida, United States, 33175
      • MeBO Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEBO/PATM cohort; 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; Behavioral nutritional counselling delivered via the Internet.; Behavioral: Stress-reduction counseling; The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
No Intervention: non-MEBO cohort; Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mebo Research, Inc.
• Collaborators: uBiome; Aurametrix

Publications and helpful links

General Publications

• Gabashvili IS Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial JMIR Dermatol 2020;3(1):e10508 URL: http://derma.jmir.org/2020/1/e10508/ doi: 10.2196/10508

Helpful Links

• uBiome Awards Grant to MEBO Research

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2018
• Primary Completion (Actual): June 16, 2019
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: microbiome; Dysbiosis; systemic malodor; body odor; bad breath; PATM; TMAU; Malabsorption
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 201805110018MEBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified patient data will be made partially available when approved by the study sponsor.
• IPD Sharing Time Frame: one year after completion of the study
• IPD Sharing Access Criteria: undecided
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No