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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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

Condition or disease Intervention/treatment Phase
Nutritional and Metabolic Diseases Behavioral: Nutritional counselling Behavioral: Stress-reduction counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dynamics of the Gut Microbiota in Idiopathic Malodor Production
Actual Study Start Date : June 16, 2018
Actual Primary Completion Date : June 16, 2019
Actual Study Completion Date : February 10, 2020

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



Primary Outcome Measures :
  1. Gut Microbiome [ Time Frame: 1 year ]
    Abundance [operational taxonomic units]


Secondary Outcome Measures :
  1. 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.

  2. Idiopathic Malodor Episodes [ Time Frame: 1 year after study enrollment ]
    The number of flareups after study enrollment

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582826


Locations
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United States, Florida
MeBO Research
Miami, Florida, United States, 33175
United Kingdom
MeBO Research LTD
London, England, United Kingdom, W10 5LE
Sponsors and Collaborators
Mebo Research, Inc.
uBiome
Aurametrix
Investigators
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Principal Investigator: Irene Gabashvili, PhD MeBO Research
  Study Documents (Full-Text)

Documents provided by Mebo Research, Inc.:
Informed Consent Form  [PDF] July 12, 2018

Additional Information:
Publications of Results:
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

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Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT03582826    
Other Study ID Numbers: 201805110018MEBO
First Posted: July 11, 2018    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (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
Informed Consent Form (ICF)
Time Frame: one year after completion of the study
Access Criteria: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mebo Research, Inc.:
systemic malodor
body odor
bad breath
PATM
microbiome
TMAU
Malabsorption
Dysbiosis
Additional relevant MeSH terms:
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Metabolic Diseases