Clinical trial NCT03582826: Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
Official title: Dynamics of the Gut Microbiota in Idiopathic Malodor Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Keywords: systemic malodor
body odor
bad breath
PATM
microbiome
TMAU
Malabsorption
Dysbiosis
Lead sponsor: Mebo Research, Inc.
Sponsor class: OTHER
Collaborators: name: uBiome
name: Aurametrix
First posted: 2018-07-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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

Primary outcomes:
measure: Gut Microbiome
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life [Score]
timeFrame: 1 year
measure: Idiopathic Malodor Episodes
timeFrame: 1 year after study enrollment
measure: Change in Fecal Microbiome Composition Between Flare-ups and Improvements
timeFrame: 1 year
measure: Alpha Diversity
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: MeBO Research
state: Florida
city: London
country: United Kingdom
facility: MeBO Research LTD
state: England
Study officials:
affiliation: MeBO Research
name: Irene Gabashvili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/e10508/ doi: 10.2196/10508