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Microbial Basis of Systemic Malodor and PATM Conditions (PATM)

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ClinicalTrials.gov Identifier: NCT03582826
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Study Participants
Nutrition counselling and stress-management counselling behavioral interventions will be given to minimize subjects symptoms and observe corresponding changes in their microbiomes
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.




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 ]
    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.

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

  3. 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



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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


Contacts
Contact: Maria de la Torre (786) 228-6880 maria.delatorre@meboresearch.org

Locations
United States, Florida
MeBO Research Recruiting
Miami, Florida, United States, 33175
Contact: Maria de la Torre    786-228-6880    maria.delatorre@meboresearch.org   
Contact: , MBA         
Principal Investigator: Irene Gabashvili, PhD         
United Kingdom
MeBO Research LTD Recruiting
London, England, United Kingdom, W10 5LE
Contact: Maria de la Torre    0800 0588015    maria.delatorre@meboresearch.org   
Sponsors and Collaborators
Mebo Research, Inc.
uBiome
Aurametrix
Investigators
Principal Investigator: Irene Gabashvili, PhD MeBO Research

Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT03582826     History of Changes
Other Study ID Numbers: 201805110018MEBO
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
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
URL: http://

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:
Metabolic Diseases