Microbial Basis of Systemic Malodor and PATM Conditions (PATM)
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|ClinicalTrials.gov Identifier: NCT03582826|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2018
Last Update Posted : June 21, 2019
|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 :||110 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|
|Estimated Study Completion Date :||December 2019|
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.
- Gut microbiome [ Time Frame: 1 year ]Abundance [operational taxonomic units]
- 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
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|