THE COVID-19 BACK-TO-NORMAL STUDY
eConsent in English
Survey en español
Conentimiento electrónico en español
See above-noted documents for privacy commitments
Our MEBO Scientific Director and Founder of Aurametrix, Irene Gabashvili, PhD., has developed and registered a Clinical Trial sponsored by MEBO Research, including MEBO US, MEBO UK, and MEBO Africa, with the collaboration of Aurametrix. The Application and (Protocol #20210103MEBO) Narrative with all applicable attachments were approved by the MEBO Research Institutional Review Board (IRB). This study is supported by both, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA), as well as the Office for Civil Rights.
This study raises the question about the effects of COVID vaccines on people with odor conditions worldwide compared to people who don’t have odor conditions. It not only looks for intensity levels of odor symptoms, but also for other short-term and long-term reactions, i.e., skin rashes, greater fatigue than prior to the vaccine, intensity levels and increase in allergic reaction, immune reactions, neurological symptoms, such as tingling sensations, muscle cramping, headaches, etc., and how they compare to the general population that does not suffer from odor conditions. If there are differences, it might open the window to further research in hopes to better understand whether these difference can lead us to a greater understanding of odor conditions in general.
As noted in the ClinicalTrials.gov site, Detailed Description of the "COVID-19 Back-to-Normal Study,"
Detailed Description: The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.
Why is this study significant for the MEBO community?
Comparing comminalities and differences in the data between sufferers and persons who do not suffer from odor conditions/PATM might give our experts a greater understanding of why some people have a greater tendency towards having an odor condition than others. Perhaps the experts might be able to more clearly identify what contributes to or causes some odor conditions.
What outcomes will be measured:
Secondary Outcome Measures :
Please note that your participation is entirely voluntary and you have the right to withdraw at any time throughout this process, as noted in the eConsent. The more people in our community from around the world volunteer to take part in this study, the more data our scientists will have at their disposal to more effectively carry out research that we hope someday will provide us with one or more treatment options, and someday, hopefully, a cure.

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2 comments:
Estoy dispuesto a participar siempre y cuando no se revele mi identidad.
También deberían de alentar a todos los de la comunidad que sufren de diferentes tipo de malos olores a participar para que haya más resultados de este ensayo clínico, entre más personas participen es mejor,estés mi punto de vista, también hace falta que nos dirijan para tratar de hacer algún tipo de conciencia al mundo sobre este tipo de henfermedad
Gracias por tu comentario. La máxima prioridad de este ensayo es proteger la privacidad de cada participante. Consulte el Consentimiento electrónico para obtener más detalles al respecto. http://bit.ly/BTN-consent-esp
y el Protocolo #20210103MEBO.
https://docs.google.com/document/d/1ARXDCOue177HaYUfMBcZF17AOwq5F9J-aNlI59o1Yn4/edit
Thank you for your comment. The utmost priority of this study is to protect the privacy of each participant. Please refer to the eConsent, http://bit.ly/BTN-consent and Protol #20210103MEBO for further details.
https://docs.google.com/document/d/1ARXDCOue177HaYUfMBcZF17AOwq5F9J-aNlI59o1Yn4/edit