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

Primary Purpose

Nutritional and Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nutritional counselling
Stress-reduction counseling
Sponsored by
Mebo Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutritional and Metabolic Diseases focused on measuring systemic malodor, body odor, bad breath, PATM, microbiome, TMAU, Malabsorption, Dysbiosis

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MeBO Research
  • MeBO Research LTD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MEBO/PATM cohort

non-MEBO cohort

Arm Description

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.

Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM

Outcomes

Primary Outcome Measures

Gut Microbiome
Abundance [operational taxonomic units]

Secondary Outcome Measures

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.
Idiopathic Malodor Episodes
The number of flareups 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
Alpha Diversity
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.

Full Information

First Posted
June 11, 2018
Last Updated
December 30, 2020
Sponsor
Mebo Research, Inc.
Collaborators
uBiome, Aurametrix
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1. Study Identification

Unique Protocol Identification Number
NCT03582826
Brief Title
Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
Acronym
PATM
Official Title
Dynamics of the Gut Microbiota in Idiopathic Malodor Production
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 16, 2018 (Actual)
Primary Completion Date
June 16, 2019 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mebo Research, Inc.
Collaborators
uBiome, Aurametrix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases
Keywords
systemic malodor, body odor, bad breath, PATM, microbiome, TMAU, Malabsorption, Dysbiosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEBO/PATM cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
non-MEBO cohort
Arm Type
No Intervention
Arm Description
Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counselling
Intervention Description
Behavioral nutritional counselling delivered via the Internet.
Intervention Type
Behavioral
Intervention Name(s)
Stress-reduction counseling
Intervention Description
The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
Primary Outcome Measure Information:
Title
Gut Microbiome
Description
Abundance [operational taxonomic units]
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life [Score]
Description
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.
Time Frame
1 year
Title
Idiopathic Malodor Episodes
Description
The number of flareups after study enrollment
Time Frame
1 year after study enrollment
Title
Change in Fecal Microbiome Composition Between Flare-ups and Improvements
Description
The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples
Time Frame
1 year
Title
Alpha Diversity
Description
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Gabashvili, PhD
Organizational Affiliation
MeBO Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
MeBO Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
MeBO Research LTD
City
London
State/Province
England
ZIP/Postal Code
W10 5LE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
Citation
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
Results Reference
result
Links:
URL
https://www.prweb.com/releases/ubiome_awards_grant_to_mebo_research_a_public_charity_to_study_the_dynamic_of_gut_microbiota_in_idiopathic_malodor_production/prweb15949159.htm
Description
uBiome Awards Grant to MEBO Research

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

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