NCT03582826

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

June 16, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

June 11, 2018

Results QC Date

August 31, 2020

Last Update Submit

December 30, 2020

Conditions

Nutritional and Metabolic Diseases

Keywords

systemic malodorbody odorbad breathPATMmicrobiomeTMAUMalabsorptionDysbiosis

Outcome Measures

Primary Outcomes (1)

  • Gut Microbiome

    Abundance \[operational taxonomic units\]

    1 year

Secondary Outcomes (4)

  • Quality of Life [Score]

    1 year

  • Idiopathic Malodor Episodes

    1 year after study enrollment

  • Change in Fecal Microbiome Composition Between Flare-ups and Improvements

    1 year

  • Alpha Diversity

    1 year

Study Arms (2)

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.

Behavioral: Nutritional counsellingBehavioral: Stress-reduction counseling

non-MEBO cohort

NO INTERVENTION

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

Interventions

Nutritional counsellingBEHAVIORAL

Behavioral nutritional counselling delivered via the Internet.

MEBO/PATM cohort
Stress-reduction counselingBEHAVIORAL

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

MEBO/PATM cohort

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MeBO Research

Miami, Florida, 33175, United States

Location

MeBO Research LTD

London, England, W10 5LE, United Kingdom

Location

Related Publications (1)

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Nutritional and Metabolic DiseasesBody OdorHalitosisMalabsorption SyndromesDysbiosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesPathologic Processes

Results Point of Contact

Title
Maria De la Torre, Executive Director
Organization
MEBO Research
maria.delatorre@meboresearch.org
786 228-6880

Study Officials

  • Irene Gabashvili, PhD

    MeBO Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 11, 2018

Study Start

June 16, 2018

Primary Completion

June 16, 2019

Study Completion

February 10, 2020

Last Updated

January 5, 2021

Results First Posted

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

Deidentified patient data will be made partially available when approved by the study sponsor.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
one year after completion of the study
Access Criteria
undecided

Locations

US(1)GB(1)