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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-16

Study Completion Date

2020-02-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Nutritional and Metabolic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nutritional counselling

Intervention Type BEHAVIORAL

Behavioral nutritional counselling delivered via the Internet.

Stress-reduction counseling

Intervention Type BEHAVIORAL

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

non-MEBO cohort

Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional counselling

Behavioral nutritional counselling delivered via the Internet.

Intervention Type BEHAVIORAL

Stress-reduction counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No