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

Mebo Research, Inc.125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

125

Conditions

Nutritional and Metabolic Diseases

Interventions

Nutritional counsellingBEHAVIORAL

Behavioral nutritional counselling delivered via the Internet.

Stress-reduction counselingBEHAVIORAL

The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (2)

MeBO Research

Miami, Florida, United States

MeBO Research LTD

London, England, United Kingdom

Outcomes

Primary Outcomes

Gut Microbiome

Abundance \[operational taxonomic units\]

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 1 year

Idiopathic Malodor Episodes

The number of flareups after study enrollment

Time frame: 1 year after study enrollment

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

Time frame: 1 year

Alpha Diversity

Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.

Time frame: 1 year

Data from ClinicalTrials.gov

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