---
title: "Microbial Basis of Systemic Malodor and \"People Allergic To Me\" Conditions"
nct_id: NCT03582826
overall_status: COMPLETED
phase: NA
sponsor: Mebo Research, Inc.
study_type: INTERVENTIONAL
primary_condition: Nutritional and Metabolic Diseases
countries: United States, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03582826.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03582826"
ct_last_update_post_date: 2021-01-05
last_seen_at: "2026-05-12T07:33:00.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions

**Official Title:** Dynamics of the Gut Microbiota in Idiopathic Malodor Production

**NCT ID:** [NCT03582826](https://clinicaltrials.gov/study/NCT03582826)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 125
- **Lead Sponsor:** Mebo Research, Inc.
- **Collaborators:** uBiome, Aurametrix
- **Conditions:** Nutritional and Metabolic Diseases
- **Start Date:** 2018-06-16
- **Completion Date:** 2020-02-10
- **CT.gov Last Update:** 2021-01-05

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 110 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **MEBO/PATM cohort** (EXPERIMENTAL) — 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.
- **non-MEBO cohort** (NO_INTERVENTION) — Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM

## Interventions

- **Nutritional counselling** (BEHAVIORAL) — Behavioral nutritional counselling delivered via the Internet.
- **Stress-reduction counseling** (BEHAVIORAL) — The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.

## Primary Outcomes

- **Gut Microbiome** _(time frame: 1 year)_ — Abundance \[operational taxonomic units\]

## Secondary Outcomes

- **Quality of Life [Score]** _(time frame: 1 year)_
- **Idiopathic Malodor Episodes** _(time frame: 1 year after study enrollment)_
- **Change in Fecal Microbiome Composition Between Flare-ups and Improvements** _(time frame: 1 year)_
- **Alpha Diversity** _(time frame: 1 year)_

## Locations (2)

- MeBO Research, Miami, Florida, United States
- MeBO Research LTD, London, England, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mebo research|miami|florida|united states` — added _(2026-05-12)_
- `locations.mebo research ltd|london|england|united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03582826.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03582826*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*