Microbial Basis of Systemic Malodor and PATM Conditions

MEBO Research, Inc.

has applied for a Mandatory Reporting of National Clinical Trial (NCT) Identifyer,

NCT03582826

and received approval from ClinicalTrial.gov for the research study,

"Microbial Basis of

Systemic Malodor and PATM Conditions (PATM)."

Sponsor: MEBO Research, Inc.
Collaborators: uBiome and Aurametrix

Dynamics of the Gut Microbiota
in Idiopathic Malodor Production

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.

What is a clinical research study?

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people.

https://www.nhlbi.nih.gov/health-topics/about-clinical-trials

What do you do in clinical trials?

A clinical trial is a research study conducted in human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective.

https://www.roche.com/research_and.../who_we.../what_is_a_clinical_trial.htm

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Participation info :
LINK English
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INSTITUTIONAL REVIEW BOARD (IRB)

In US, an IRB (Institutional Review Board) must approve proposed non-exempt research before involvement of human subjects may begin. All our clinical investigations are reviewed by MeBO Research IRB00010169 (FWA00026547 expires on 02/14/2023), registered with The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) through a system maintained by the US Department of Health and Human Services (DHHS), as required under 21 CFR part 56, subpart B, and 45 CFR part 46, subpart E.

http://aurametrix.com/studies.html

The whole MEBO international community around the world is most grateful to uBiome for their very generous research grant and to the Founder of Aurametrix and MEBO Scientific Director, Irene Gabashvili, PhD., for her pro-bono services as the Principal Investigator of this study.

María

María de la Torre
Founder and Executive Director

A Public Charity
maria.delatorre@meboresearch.com
www.meboresearch.org
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