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

Mebo Research

Status: Completed

Conditions: Nutritional and Metabolic Diseases

Treatments: Behavioral: Nutritional counselling; Behavioral: Stress-reduction counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03582826

201805110018MEBO

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

MEBO/PATM cohort

Experimental group

Description:

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.

Treatment:

Behavioral: Stress-reduction counseling

Behavioral: Nutritional counselling

non-MEBO cohort

No Intervention group

Description:

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