NCT03582826 ClinicalTrials.gov MEBO Gut Microbiome Study "Microbial Basis of Systemic Malodor and PATM Conditions (PATM)" Funded by uBiome Research Grant
"Microbial Basis of Systemic Malodor and PATM Conditions (PATM)"
Dynamics of the Gut Microbiota in Idiopathic Malodor Production & PATM
Denver TMAU Test Lab survey click here click to Read more/less
USA survey for anyone who wants to improve Denver TMAU test
begun : Dec22 end : no ending for now
A trainee genetic counselor is working at the Denver TMAU test lab. Probably as part of her training. As a project she wishes feedback on any aspect of the Denver TMAU test and process. You can fill in the survey and/or email her (email address is in survey). It's meant for USA people, but perhaps others can give their view too (as we have so few opportunities).
quote from her rareconnect post
"Hello all! I wanted to make you aware of a research study being conducted to better understand the experience and needs of individuals with trimethylaminuria with a goal of being able to create improved patient and healthcare provider education materials. Any participation is completely voluntary and all responses remain confidential. Feel free to use the contact information within the link with any questions or share the survey with others with TMAU."
Although systemic malodor is commonly overlooked by physicians, it constitutes a major problem for many otherwise healthy people. Yet, this condition has thus far eluded effective treatments or cures in many individuals. The number of potentially responsible SNPs, genes, microbes and related disorders is large and keeps increasing, overlapping with confounders of COVID-19.
Decentralized observational study NCT04832932 compared MEBO participants to general populations in respect to their response to COVID-19 vaccines and SARS-Co-V2 infections.
Body odor flareups were observed in about 10% of current or former malodor sufferers after vaccination, as preliminarily reported. This number was similar to flareups of other chronic symptoms in groups of participants with gastrointestinal and autoimmune disorders.
Long-term worsening of body odor was observed by other researchers after COVID-19 vaccination in about ~1% of studied populations. Dry mouth leading to halitosis was 10 times more prevalent compared to flu vaccines. MEBO participants reported stronger reactions than general population pointing to genetic and microbiome influences beyond FMO3.
A better understanding of systemic malodor conditions could offer leads for targeted therapies. Findings on genetic and microbiome overlaps between COVID-19 and MEBO could pave the way for precision medicine to address the unmet needs of odor sufferers.
PATM and malodor conditions may develop during and after an episode of infectious disease.
Our preliminary results suggest that this can happen in long COVID. Other groups are finding this too. A paper by a team from France, led by veterinary scientist Dominique Grandjean, posted their work today on MedRxiv. It shows that dogs can easily recognize characteristic body odor up to 1.5 year after the initial phase of COVID-19 in at least half of Long COVID patients.
Interestingly, post-COVID symptoms associated with worsening odor are similar to symptoms observed in our COVID study. Some MEBO participants reported flare-ups of their (previously well controlled) condition post-COVID or temporary excacerbation of body odor post-vaccine.
Your observations, hypotheses and comments are most welcome. Comment here, e-mail us or use the survey for anonymous feedback. Feel free to skip most or all the fields in the survey except the last line:
The COVID-19 pandemic has had a profound effect on communities and MEBO community is not an exception. Planned diagnostic and therapeutic studies were put on hold or transitioned from collecting new data to just analyzing the data. Any disadvantage, however, can be turned into an advantage. COVID-19 can help us to learn more about FMO3, distorted sense of smell, gut dysbiosis and other conditions contributing to malodor syndromes. Observations about COVID-19/vaccine reactogenicity in the MEBO community could help to attract researchers' interest and design better interventions against malodor conditions.
The COVID-back-to-normal study (registered as NCT04832932) follows about 1000 participants from different online and offline communities and compares their susceptibility to SARS-CoV-2 infection, reactions to vaccines, COVID- and post-COVID symptoms.
Preliminary results suggest there are interesting differences between the MEBO community and others.
It is not unexpected. This figure from a recent article in Nature Medicine shows that FMO3 is one of the genes whose expression correlates with ACE2, the gene employed by SARS-CoV-2 for cellular entry. A few other potential links between TMAU and COVID-19 are discussed in the latest Aurametrix blog.
Your observations, hypotheses and comments are most welcome.
The research protocol was approved by MEBO Research IRB before it was open to the MEBO community around the world, which states the following reasons this study is being conducted,
COVID-19 vaccines were tested in clinical trials with thousands of participants before authorization, and were administered to over a billion people across the globe in the following 6 months… Vaccinated individuals were also posting their experiences on multiple social media groups created on Facebook, Reddit, Telegram and other platforms, but the groups were often removed as “proliferating false claims”. These forms of reporting are susceptible to biases and misclassifications and do not reach all vaccinated individuals, raising questions about risks of exacerbating health inequalities as well as security and privacy vulnerabilities… https://www.medrxiv.org/content/10.1101/2021.06.28.21256779v1
Possible worsening of MEBO/PATM symptoms after vaccinations was reported by 10% of study participants.
Comparing data from the COVID-19 Back-to-Normal Clinical Trial to published data of other studies matching by ages and vaccines, indicate that the short-term effects are very similar. However, as our Principal Investigator, Irene Gabashvili, PhD, tells us in her Aurametrix blog post,
More significant differences were for less common and longer-term effects [after vaccination] including fast heartbeat, dry mouth, skin reactions and swollen lymph nodes…Possible worsening of MEBO/PATM symptoms after vaccinations was reported by 10% of study participants.
THE MEBO COMMUNITY AND COVID-19 INFECTIONS
Irene’s early results show a significant difference of MEBO group from the general population in the response to COVID-19 infection, and points out how the rate of “long-haulers,” who had long term adverse symptoms after contracting COVID-19, is close to some groups with severe genetic conditions,
Our rate is closer to some groups with severe genetic conditions
The most significant difference of MEBO group from the general population is the response to COVID-19 infection. 6 people (3 males, 3 females) out of 41 study participants experienced COVID-19 and all of them had long-term reactions. 5 out of 6 considered themselves long-haulers. The 6th person reported persistent MEBO/PATM issues post-acute COVID-19. That's 80-100% of long-haulers, ~4 times more than researchers estimate! Our rate is closer to some groups with severe genetic conditions - such as individuals with hypohidrotic ectodermal dysplasia - predisposing to bad smell from nostrils.
Community immunity (also known as herd immunity) protects everyone. We hope that MEBO/PATM community stays COVID-free and safe.
Gold JE et al. Study 2021
In her early results, Irene makes reference to a new study by Gold and his colleagues*, which argues,
...long-haulers might actually be experiencing an attack of fatigue-inducing Epstein-Barr virus (EBV, a member of herpesvirus family HHV-4) that was lying dormant in their bodies…Vaccines were shown to reactivate viruses too, in much rarer cases. As was demonstrated for Pfizer vaccine that woke up another herpes virus, chickenpox herpes-zoster (HHV-3), that causes shingles when reactivated (this happened to 1% of patients with autoimmune inflammatory rheumatic diseases). Herpes simplex (HSV-1) can be also kept in remission by a healthy immune system and can be also reactivated by COVID-19.
Irene raises the following suggestion, “MEBO and PATM symptoms could arise following an infection. Perhaps SARS-CoV-2 can reactivate the old viruses that caused these symptoms to begin with?” In fact, many sufferers in the MEBO community around the world have pointed out countless times that their difficult-to-control, long-term odor condition was originally triggered following a course of antibiotics for a serious infection.
*Gold JE, Okyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and Its Relationship to Epstein-Barr Virus Reactivation. Pathogens. 2021 Jun;10(6):763.
The MEBO community around the world profoundly appreciates Irene's dedication of over a decade to seeking answers to the various odor & PATM conditions of our members.
Survey in English eConsent in English Survey en español Conentimiento electrónico en español
See above-noted documents for privacy commitments
One week after MEBO launched this study, our MEBO Scientific Director and Founder of Aurametrix, Irene Gabashvili, PhD, writes her first post in her Aurametrix Blog about the preliminary results based on the responses to the survey of the 24 member of the MEBO community and 6 of their family members from various countries around the world. The responses refers to reactions to the Astrazeneca, J&J, Moderna, Pfizer and Sinovac/Coronavac vaccines, documenting the reactions sufferers of breath and body odor have experienced.
Urine and axillary odor are becoming slightly more aversive in healthy humans, as a function of immune activation. But this is not supposed to last too long… Interestingly, Pfizer vaccine that caused no or very mild reactions in several MEBO participants, was also the vaccine that possibly caused temporary worsening of odor symptoms in one person in the community. Another MEBO participant that reported possible worsening of odor from Moderna vaccine had one thing in common with the other individual - they both had pre-existing conditions related to their upper digestive tract. Some Astrazeneca recipients also reported odor issues but did not think it was worse than usual…We'll be posting more observations and comparisons with over 600 participants of our study from other communities.
I [Irene] have a lot of data now on bad adverse reactions to vaccines, so I can answer any questions to those who are still hesitant.
These are just very preliminary results, of course, only one week into the study, and the goal is to ultimately compare them to other communities of persons who do not suffer from odor conditions to determine whether there may be any significant differences.
Irene requests the following from us:
It would be interesting to know if we had more cases of (possible) COVID infections in the group.
We can accept people's stories as e-mails or PMs to maria.delatorre@meboresearch.org or irene.gabashvili@meboresearch.org
.
It's OK to skip some questions in the survey.
Even if you were never vaccinated, you are welcome to share your observations about COVID infections or how they avoided COVID.
Message to our community from Irene:
I have a lot of data now on bad adverse reactions to vaccines, so I can answer any questions to those who are still hesitant. irene.gabashvili@meboresearch.org. I mean, I agree that some people should be very careful about vaccination as certain pre-existing conditions could cause really bad reactions. Even more so if infected. It's better to know what to expect and to be prepared.
Thank you, Irene for all you do for us on a pro-bono basis. Your dedication to our MEBO community around the world is greatly appreciated beyond words!
Survey in English 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?
MY PERSONAL OPINION
Since 2009, the 4 Clinical Trials that MEBO has carried out has addressed the microbial basis of systemic malodor and PATM conditions, explored the relationships between malodor and urine metabolomes as well as volatile organic compounds in alveolar breath, which may shed some light on the relationship of the microbiota, gut dysbiosis and impaired metabolism with immunity to pathogens and vaccines and tolerance to antigens.
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.
your participation is entirely voluntary and you have the right to withdraw at any time throughout this process, as noted in the eConsent.
The study is estimating to enroll 1,000 participants, and we hope to include a significant number of MEBO participants to be able to acquire a stronger based data on how sufferers of odor conditions/PATM reacted to any and all COVID-19 vaccines, compared to non-sufferers. Please participate by asking for a MEBO ID# from maria.delatorre@meboresearch.org to proceed to take the 16 question survey inEnglish or in Spanish.
What outcomes will be measured:
Primary Outcome Measures :
1. Adverse reactions/events [ Time Frame: 10 days post-doses 1 and 2 ]
Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2
Secondary Outcome Measures :
1. Long-term adverse events [ Time Frame: Throughout the study period, until 12 months post-final-dose ]
Percentage of occurrence, types, duration and severity of adverse events throughout study period
2. Percentage of participants with COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose ]
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.
AmazonSmile customers can now support MEBO Research Inc. in the Amazon shopping app on iOS and Android mobile phones! Simply follow these instructions to turn on AmazonSmile and start generating donations. Open the Amazon Shopping app on your device Go into the main menu of the Amazon Shopping app and tap into 'Settings' Tap 'AmazonSmile' and follow the on-screen instructions to complete the process
Donate to MEBO
US DOLLARS
Or CLICK HERE Or go to your paypal.com account and send as 'gift' to
If you go through these links and don't use MEBO on SMILE, MEBO will get ~4%
But ppl forget about these links ....so if u forget then choose MEBO in AMAZON SMILE
MEBO will get 0.5%
but 0.5% of something beats 4% of nothing
Buy your Amazon purchases through here
Amazon USA
Go to Amazon through the banner above or the link below : if you buy anything, MEBO gets a small percentage commission at no extra cost to you. No personal details are given to MEBO (see Disclosure below).
Do your Amazon shopping through the links and MEBO gets 5-10% commission at no extra cost to you
Amazon Affiliate Disclosure: MEBO Research is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to amazon.com, or endless.com, MYHABIT.com, SmallParts.com, or AmazonWireless.com.
TOTAL DONATIONS: $267.48 = £159.47 (30AUG14) 1st shipment to Kenya 3JUN14 $92.75/USD 2nd shipment to Ghana 15AUG14 $104.56/USD 3rd shipment to Kenya 19SEP14 $95.51/USD DONATIONS 2017: £5.00 (3MAR17)
![[Facebook Share]](https://lh3.googleusercontent.com/blogger_img_proxy/AEn0k_vrnxKvzNS-cMesoB4gkDq00IGR4LoPNzdcHIyllPqeRohJyH0Cov1dNJGuIWMO_PMqYAt2_X18TCmYoG0qJQccfjC_OE0=s0-d){kind=small}
UK 
Spain 
