a PATIENT ADVOCACY International campaign to research SYSTEMIC BODY ODOR AND HALITOSIS
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Approved Exploratory Research Study
Exploratory Study of Relationships Between Malodor and Urine Metabolomics
Exploratory Study of Relationships Between Malodor and Urine Metabolomics
(ID: 201505010014MEBO/ NCT02683876)
Clinicaltrials.gov is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This site receives over 200 million views per month and 65,000 unique visitors daily.
I am very excited to announce that on February 16, 2015, the new MEBO Research sponsored clinical trials, the Exploratory Study of Relationships Between Malodor and Urine Metabolomics (ID: 201505010014MEBO) has been approved and assigned research number NCT02683876 by the U.S. Clinical Trials.gov Protocol Registration and Results System after they reviewed the protocol information that fulfilled their requirements and received the human subjects review board approval from the MEBO Institutional Review Board (IRB). This information can be found on the Clinical Trials website at,
https://clinicaltrials.gov/ct2/results?term=NCT02683876&Search=Search
Clinicaltrials.gov is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This site receives over 200 million views per month and 65,000 unique visitors daily.
Metabolic profiles will be identified using the metabolomics equipment located in the NMR, HPLC, and MS facilities of the Metabolomics Innovation Centre (TMIC).
In this study, metabolite profiling analysis will be carried out on urine samples of individuals with malodor conditions related to metabolism inefficiencies. Metabolic profiles will be identified using the metabolomics equipment located in the NMR, HPLC, and MS facilities of the Metabolomics Innovation Centre (TMIC). Multivariate statistical analyses will be used, as well as other approaches to mine complex data from heterogeneous sources.PURPOSE OF THIS STUDY
The pilot study is commencing involving participants who reside in Canada and suffer from a malodor condition, and based on results, will expand to include sufferers from other countries.
FOR NUTRITIONAL AND METABOLIC DISEASES
RESULTING IN MALODOR CONDITIONS
RESULTING IN MALODOR CONDITIONS
The purpose of this study is to identify metabolic signatures associated with malodor conditions. The investigators will perform state-of-the art metabolomics tests and bioinformatic data mining to explore whether conditions leading to malodor can be screened by metabolomic profiling of urine samples.
So we are ready to start the study and are excited to work with Dr. Wishart.
PRIMARY OUTCOME MEASURES
Differences in metabolite concentrations measured by mass spectrometry, comparing urine samples from individuals with malodor issues, and age-matched healthy controls. The investigators would like to validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with malodor.
SECONDARY OUTCOME MEASURES
Correlations between urine biomarkers and frequency/severity of malodor symptoms (questionnaires). The investigators will comprehensively analyze the ability of metabolite levels to discriminate frequent and severe from non-severe malodor symptoms.
GROUPS/COHORTS
- Subjects with malodor: individuals with self-reported odor issues suspected to be associated with microbial imbalance on or inside the body and inefficient metabolism as evidenced from other laboratory tests.
- Healthy control: individuals not complaining of uncontrollable or unpredictable malodor episodes.
RECRUITMENT
All recruitment will be performed exclusively by MEBO.
All recruitment will be performed exclusively by MEBO. Anyone interested in participating in this program can express interest by email to maria.delatorre@meboresearch.org. Please provide your legal name, address, and email address where you will be contacted to be invited to participate in the study. At the present time, the pilot study is commencing involving participants who reside in Canada and suffer from a malodor condition, and based on results, will expand to include sufferers from other countries. If you qualify and are interested in being a participant in the pilot study and have not yet been contacted, please express interest to the email above.
CONFIDENTIALITY
In an effort to maintain the integrity of the study, the staff at TMIC will not have any of your personal information, and you may be disqualified from the study if you contact the lab directly and divulge personal information.
Confidentiality is of the utmost important to MEBO and to this study. All information will remain confidential, and no one outside the MEBO staff in charge of this program will not have access to any of your personal information. In an effort to maintain the integrity of the study, the staff at TMIC will not have any of your personal information, and you may be disqualified from the study if you contact the lab directly and divulge personal information. All contact must be made through MEBO exclusively. Your cooperation in this matter would be greatly appreciated.
María de la TorreFounder and Executive Director
A Public Charity
maria.delatorre@meboresearch.com
www.meboresearch.org
www.mebo.com.br/
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4 comments:
Maria is this related to Trinzyme in anyway? Wouldn't this exploratory study benefit Trinzyme?
What a great study! I can't wait to be a part of it. Not only will it guide us to identify other malodor diseases it can also let us know what to avoid in our diet, if low choline isn't working for us.
Hi Anonymous,
No, the MEBO Metabolomic Profile research is not related to Trinzyme in any way. Trinzyme is concentrating more a treatment forTMAU, whereas, the MEBO metabolomic research is all about identifying metabolites and their levels in the urine to compare them to participants that do not suffer from odor conditions. The hope of carrying out this exploratory study is to create a metabolomic profiles of one or more odor conditions. This will probably include TMAU, as well as others yet to be identified, which we hope this research will do.
It's impossible to control or cure a condition that has not been discovered (identified). This will be step #1.
I agree Stephanie. And more importantly, it will guide sufferers who do not have TMAU towards a better targeted protocol, as opposed to a low choline diet, which they don't need and is bad for their liver.