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

• 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: Mebo Research, Inc.
• Collaborators: uBiome; Aurametrix
• Information provided by (Responsible Party): Mebo Research, Inc.

Tracking Information

• First Submitted Date: June 11, 2018
• First Posted Date: July 11, 2018
• Results First Submitted Date: August 31, 2020
• Results First Posted Date: January 5, 2021
• Last Update Posted Date: January 5, 2021
• Actual Study Start Date: June 16, 2018
• Actual Primary Completion Date: June 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 30, 2020)

Gut Microbiome [ Time Frame: 1 year ]

Abundance [operational taxonomic units]

Original Primary Outcome Measures (submitted: June 27, 2018)

Gut microbiome [ Time Frame: 1 year ]

Abundance [operational taxonomic units]

Current Secondary Outcome Measures (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 (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: Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Nutritional and Metabolic Diseases

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2020): 125
• Original Estimated Enrollment (submitted: June 27, 2018): 100
• Actual Study Completion Date: February 10, 2020
• Actual Primary Completion Date: June 16, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 110 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT03582826
• Other Study ID Numbers: 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

• 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

• Current Responsible Party: Mebo Research, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Mebo Research, Inc.
• Original Study Sponsor: Same as current

Collaborators

• uBiome
• Aurametrix

Investigators

• Principal Investigator: Irene Gabashvili, PhD; MeBO Research

• PRS Account: Mebo Research, Inc.
• Verification Date: December 2020