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

Nutritional and Metabolic Diseases Clinical Trial

— PATM  

Official title:

Dynamics of the Gut Microbiota in Idiopathic Malodor Production

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582826
• Other study ID #: 201805110018MEBO
• Status: Completed
• Phase: N/A
• Start date: June 16, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: December 2020
• Source: Mebo Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 10, 2020
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Behavioral:
• Nutritional counselling
Behavioral nutritional counselling delivered via the Internet.
• Stress-reduction counseling
The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.

Locations

Country	Name	City	State
United Kingdom	MeBO Research LTD	London	England
United States	MeBO Research	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Mebo Research, Inc.	Aurametrix, uBiome

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (1)

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/e

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome	Abundance [operational taxonomic units]	1 year
Secondary	Quality of Life [Score]	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.	1 year
Secondary	Idiopathic Malodor Episodes	The number of flareups after study enrollment	1 year after study enrollment
Secondary	Change in Fecal Microbiome Composition Between Flare-ups and Improvements	The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples	1 year
Secondary	Alpha Diversity	Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.	1 year

External Links

•   uBiome Awards Grant to MEBO Research