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

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ClinicalTrials.gov Identifier: NCT03582826
Recruitment Status : Completed
First Posted : July 11, 2018
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
uBiome
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE July 11, 2018
Results First Submitted Date  ICMJE August 31, 2020
Results First Posted Date  ICMJE January 5, 2021
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE June 16, 2018
Actual Primary Completion Date June 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
Gut Microbiome [ Time Frame: 1 year ]
Abundance [operational taxonomic units]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
  • Quality of Life [Score] [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year after study enrollment ]
    The number of flareups after study enrollment
  • Change in Fecal Microbiome Composition Between Flare-ups and Improvements [ Time Frame: 1 year ]
    The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples
  • Alpha Diversity [ Time Frame: 1 year ]
    Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • Quality of Life [Score] [ Time Frame: 1 year ]
    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) 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. MEBO test provides a total QOL score (minimum score of 20 and maximum score of 150) and is focusing on four aspects of QOL: physical health, psychological health, social support and environment.
  • Idiopathic Malodor Episodes [ Time Frame: 1 year after study enrollment ]
    The number of flareups after study enrollment
  • Change from Baseline in Fecal Microbiome Composition [ Time Frame: 1 year ]
    The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
Official Title  ICMJE Dynamics of the Gut Microbiota in Idiopathic Malodor Production
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Nutritional and Metabolic Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Nutritional counselling
    • Behavioral: Stress-reduction counseling
  • No Intervention: non-MEBO cohort
    Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2020)
125
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
100
Actual Study Completion Date  ICMJE February 10, 2020
Actual Primary Completion Date June 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582826
Other Study ID Numbers  ICMJE 201805110018MEBO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified patient data will be made partially available when approved by the study sponsor.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: one year after completion of the study
Access Criteria: undecided
Responsible Party Mebo Research, Inc.
Study Sponsor  ICMJE Mebo Research, Inc.
Collaborators  ICMJE
  • uBiome
  • Aurametrix
Investigators  ICMJE
Principal Investigator: Irene Gabashvili, PhD MeBO Research
PRS Account Mebo Research, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP