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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.

June 11, 2018
July 11, 2018
July 11, 2018
June 16, 2018
May 2019   (Final data collection date for primary outcome measure)
Gut microbiome [ Time Frame: 1 year ]
Abundance [operational taxonomic units]
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Microbial Basis of Systemic Malodor and PATM Conditions
Dynamics of the Gut Microbiota in Idiopathic Malodor Production
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.

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.

Interventional
Not Applicable
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Nutritional and Metabolic Diseases
  • 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.
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
Interventions:
  • Behavioral: Nutritional counselling
  • Behavioral: Stress-reduction counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
December 2019
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 110 Years   (Adult, Older Adult)
No
Contact: Maria de la Torre (786) 228-6880 maria.delatorre@meboresearch.org
United Kingdom,   United States
 
 
NCT03582826
201805110018MEBO
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Mebo Research, Inc.
Mebo Research, Inc.
  • uBiome
  • Aurametrix
Principal Investigator: Irene Gabashvili, PhD MeBO Research
Mebo Research, Inc.
June 2018

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