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
|Condition or disease||Intervention/treatment||Phase|
|Nutritional and Metabolic Diseases||Behavioral: Nutritional counselling Behavioral: Stress-reduction counseling||Not Applicable|
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)|
|Actual Enrollment :||125 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|
|Actual Primary Completion Date :||June 16, 2019|
|Actual Study Completion Date :||February 10, 2020|
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
- Gut Microbiome [ Time Frame: 1 year ]Abundance [operational taxonomic units]
- 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.
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
|United States, Florida|
|Miami, Florida, United States, 33175|
|MeBO Research LTD|
|London, England, United Kingdom, W10 5LE|
|Principal Investigator:||Irene Gabashvili, PhD||MeBO Research|