In short - one person whom I know from another forum is a long term advocate of research on gut microbiome and fecal microbiota transplantation - it's an exciting area of study that will help treat a wide variety of human diseases in the future. He's a disabled person with little financial resources and has been advocating on various science- and disease-related places on the internet for years but was met with either hostility or apathy. He would welcome any kind of help but currently, his main goal is to get as many people from the US to e-mail the Congresspeople.

This is his letter to US legislators, summarizing his work: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/#post-1370

This is his advocacy history and his complaints about what's been happening with the FMT: https://forum.humanmicrobiome.info/threads/continued-letters-and-complaints-to-the-fda-nih-and-hhs-jan-2025-fmt.842/

He should join this forum soon. He asked me to create a thread in his name since I'm already a known forum member.

A note to moderators: If linking to another forum breaks forum rules, do not close this thread. Either remove the links or PM me and I'll do it myself. It's important for me that this thread stays open.

With regards.

Edited July 18Jul 18 by Otto Kretschmer

Thank you Otto! Hello everyone, I'm the disabled patient who has been trying to get access to FMT for over a decade. You can see later in the first linked thread that I've been living in my car in DC since November 2024, visiting the Congressional offices most days, trying to get someone in Congress to solve the issue.

One of their staffers recently indicated to me that they basically ignore individuals and only take action if enough people contact them, so that's my current focus.

I'm happy to answer any questions.

Research into gut microbiome and also the gut-brain axis is quite important. I've had some experience with the issue as it impacts C-section infants in later life (they don't receive as much gut microbiota from the mother, and have higher rates of enteric health problems). Can you provide a brief summary of what you see as the funding problems for such research? (Aside from the obvious problems with the current "small gubment" and anti-science ethos in DC).

2 hours ago, TheVat said:

Can you provide a brief summary of what you see as the funding problems for such research?

The primary issues are not with funding, they're with FMT donor quality. It's summarized in the first link in the OP, and elaborated on in the second link.

3 hours ago, Michael Harrop said:

The primary issues are not with funding, they're with FMT donor quality. It's summarized in the first link in the OP, and elaborated on in the second link.

Even if you were given a FMT with a suitable profile, will your dietary habits and its composition preserve what has been put there medically in the long term? Are you eating additives that harm your intestinal flora, and you need to provide the right foods (prebiotics) so that the bacteria you have can do their job feeding the gut cells with low molecular fatty acids and maintaining overall gut homeostasis.

20 hours ago, StringJunky said:

Even if you were given a FMT with a suitable profile, will your dietary habits and its composition preserve what has been put there medically in the long term?

Our gut environment also changes with age, and lifestyle. And that in turn influences the gut composition in addition to diet in the mid- to long-term. That is, even a diet change might not be able to fundamentally change the intestinal environment and might lead to a continued shift to unfavorable gut microbiota (though there is also uncertainty regarding the specifics of that).

The scientific case for expanding microbiome-based therapies is strong. FMT has shown efficacy in recurrent C. difficileinfections and is being investigated for a range of conditions, including inflammatory bowel disease, metabolic disorders, and neuropsychiatric conditions. However, regulatory frameworks in the US remain cautious, possibly due to concerns about safety, standardization, and long-term effects. His frustration is understandable given the potential benefits and the slow pace of institutional response.

20 minutes ago, Sohan Lalwani said:

The scientific case for expanding microbiome-based therapies is strong. FMT has shown efficacy in recurrent C. difficileinfections and is being investigated for a range of conditions, including inflammatory bowel disease, metabolic disorders, and neuropsychiatric conditions. However, regulatory frameworks in the US remain cautious, possibly due to concerns about safety, standardization, and long-term effects. His frustration is understandable given the potential benefits and the slow pace of institutional response.

Yes - gut microbiota is even involved in autism. And Alzheimer's. But as @Michael Harrop said, the main issue is poor donor quality, he's looking for extremely high quality donors that are very rare according to the research he has done.

Edited July 20Jul 20 by Otto Kretschmer

12 minutes ago, Otto Kretschmer said:

Yes - gut microbiota is even involved in autism. And Alzheimer's

I think the evidence is a bit weak, there are associations, but it is unclear if there is functional involvement. There are some data from animal studies but at least from what I have read the effect size an potential mechanistic linkages are weak. While the gut brain axis is a hot topic, there is a risk (as with many other hot topics before) to overstate early findings and to conflate associations with causative linkages. These are complex interactions on multiple levels (development, environment, genetics, immune system etc.) and focussing on one aspect tend to create appealing, but often non-viable models.

Edit: perhaps to at least slightly outline the difficulties in understanding this link. The gut brain axis is not a singular mechanism, but rather a collective term for the many interactions between bacteria and microbial molecules in the gut with many elements of the host and conversely, the many interactions between host and the gut microbiota. The interactions modulate what and how much of the various signaling molecules are being produced and then interact with a range of other mechanisms, such as the endocrine and immune system, but also the notably the central nervous system. The axis really means that there is signaling between these compartments, many of which we already knew for a long time, but the new element is how the gut microbiome seems to modulate these elements. The tricky bit here is that all the involved mechanisms, such as the endocrine system, CNS and immune system are also affected by a plethora of stimuli and developmental factors that happen outside of this axis. Moreover, each of the systems, (especially in my mind the immune system) are highly dynamic, complex and generally poorly understood from a biological perspective. While in the medical field there is always a quest to try to find a singular factor that then can be treated, from a more systems biological perspective, in many cases it will be futile or the effect might be less than desired.

It doesn't mean that research in that area is futile as there will be incremental advances, but too often (cancer research is another area) folks overfocus singularly on one aspect while forgetting that biology is almost always a complex interplay of many, typically only partially understood mechanisms.

1 hour ago, CharonY said:

I think the evidence is a bit weak, there are associations, but it is unclear if there is functional involvement. There are some data from animal studies but at least from what I have read the effect size an potential mechanistic linkages are weak. While the gut brain axis is a hot topic, there is a risk (as with many other hot topics before) to overstate early findings and to conflate associations with causative linkages. These are complex interactions on multiple levels (development, environment, genetics, immune system etc.) and focussing on one aspect tend to create appealing, but often non-viable models.

Here is a list of evidence to the contrary: https://humanmicrobiome.info/brain/. Causation has been well-established for years.

"Complex interactions" is certainly correct. However, it's been shown that correcting gut dysbiosis, usually via FMT, addresses the root cause.

Your last sentence refers to the gut microbiome as "one aspect", and lists "other aspects". You can see in that same wiki that the gut microbiome regulates the immune system, epigenetics, and development. So I think it's inaccurate to view it like that.

Wouldn't it be more appropriate & on-topic to have that discussion in another thread? A number of the comments here seem off-topic.

Edited July 20Jul 20 by Michael Harrop

I second @Michael Harrop, it's better to start a second, more general purpose thread about the gut microbiome.

EDIT: Done: https://scienceforums.net/topic/136452-gut-microbiome-general-discussion-thread/

Edited July 20Jul 20 by Otto Kretschmer

5 hours ago, Otto Kretschmer said:

main issue is poor donor quality, he's looking for extremely high quality donors that are very rare according to the research he has done.

In keeping with forum rules, OP should provide a definition of what constitutes a "high quality donor" and not just point towards a link to be clicked on. And the general gut biome discussion IS germane to this topic insofar as present knowledge informs the definition of what high quality is, and how quality would be determined for a specific transplant recipient.

3 hours ago, Michael Harrop said:

Here is a list of evidence to the contrary: https://humanmicrobiome.info/brain/. Causation has been well-established for years.

This site, while it may be an impressively large citation dump, has a lot of references that are not to peer-reviewed primary research, and seems very slanted to a pro FMT perspective. Causal connections along the GB axis are not as well-established as you claim. You are hopeful, but you shouldn't get ahead of yourself.

I would keep in mind Charon's observation...

5 hours ago, CharonY said:

The tricky bit here is that all the involved mechanisms, such as the endocrine system, CNS and immune system are also affected by a plethora of stimuli and developmental factors that happen outside of this axis. Moreover, each of the systems, (especially in my mind the immune system) are highly dynamic, complex and generally poorly understood from a biological perspective. While in the medical field there is always a quest to try to find a singular factor that then can be treated, from a more systems biological perspective, in many cases it will be futile or the effect might be less than desired.

4 hours ago, Otto Kretschmer said:

I second @Michael Harrop, it's better to start a second, more general purpose thread about the gut microbiome.

EDIT: Done: https://scienceforums.net/topic/136452-gut-microbiome-general-discussion-thread/

Moderator Note

Discussion needs to be focused. We don't want a bunch of threads on this until there is a reason for it. Stay in this thread, the other one is closed.

9 hours ago, Otto Kretschmer said:

@Michael Harrop said, the main issue is poor donor quality, he's looking for extremely high quality donors that are very rare according to the research he has done.

One practical solution to finding good donors is to partner with health-focused communities and institutions where people are more likely to have excellent gut microbiome profiles. This could include fitness clubs, university wellness programs, or even groups that follow long term plant based or even Mediterranean diets. By offering small incentives and educating people on the importance of their role in medical research, you can encourage participation from a broader and potentially healthier donor base. After initial lifestyle and health screenings, a smaller group can undergo more detailed stool analysis to check for microbial diversity, presence of beneficial species, and absence of harmful pathogens. Using this two step approach helps filter out unsuitable candidates early while focusing resources on testing those more likely to meet the high standards required. Creating a small registry of top tier donors from this process would allow for better consistency and scalability in treatments.

15 hours ago, TheVat said:

In keeping with forum rules, OP should provide a definition of what constitutes a "high quality donor"

Correct me if I am wrong, but I believe the correct term for "high quality donors" in this case should be called "super donors"

If I were to put it very simply, a good gut microbiome donor is someone who is healthy and free from any infections or diseases that could be passed on. They should not have taken antibiotics recently because those medicines can disrupt the natural balance of bacteria in the gut. Their gut bacteria should be diverse and balanced, which usually comes from a healthy diet and lifestyle without smoking or excessive alcohol. The donor must not have any digestive problems or chronic illnesses like diabetes or autoimmune diseases because these can affect the quality of their gut microbes. Before donating, they need to be carefully tested to make sure they do not carry any harmful bacteria, viruses, or parasites. Overall, a good donor has a strong and stable community of beneficial bacteria that can help improve someone else’s gut health safely.

23 hours ago, TheVat said:

OP should provide a definition of what constitutes a "high quality donor"

I would say "safe and effective". Many of the current quality of donors get poor results and even harm patients.

7 hours ago, Sohan Lalwani said:

"high quality donors" in this case should be called "super donors"

Either one is fine. What's the opposite for "super-donor"? "High-quality donor" has an easy opposite.

22 hours ago, Phi for All said:

Discussion needs to be focused.

That would be nice. Unfortunately, most of the comments so far are off-topic.

I guess the problem here is the same as in most of the general public -- most people aren't well-informed enough to have the motivation to take action, and most people lack the motivation to become well-informed on this. Thus, patients like me are sentenced to a slow death while an existing cure remains beyond our reach.

2 hours ago, Michael Harrop said:

Either one is fine. What's the opposite for "super-donor"?

Super-bad donor (joking).

I highly suggest everyone reads the content of the links included in the OP before posting: That's what @Michael Harrop expects everybody to do.

First link:

Letter to legislators:

Title: The FDA, FMT (fecal microbiota transplant), right to try

The full details are in these blogs:https://www.humanmicrobes.org/blog

Especially these two:

• FDA and FMT part 1 https://www.humanmicrobes.org/blog/fda-fmt-regulation

• FDA and FMT part 2 https://www.humanmicrobes.org/blog/the-fda-and-fmt-regulation-part-2

The summary is that the FDA is preventing patients from being able to access a treatment, and likely cure, for many diseases because they are classifying poop as an unapproved drug. None of the existing Right To Try laws cover this scenario. There is no monetary incentive for any pharmaceutical company to make FMT available from high-quality (safe and effective) donors. So a patient had to take things into their own hands, and now the FDA is shutting them down. High-quality donors will never be available any other way.

Here are the key points.

• The gut microbiome influences every aspect of human health and development. https://humanmicrobiome.info/intro/

• FMT (fecal microbiota transplant) is the most studied and promising intervention to correct "gut dysbiosis", and thus treat, and potentially cure, numerous diseases. It transfers the beneficial microbes from a healthy person to a sick person. https://humanmicrobiome.info/fmt/

• People healthy enough to be highly safe & effective donors are very rare. https://forum.humanmicrobiome.info/threads/while-antibiotic-resistance-gets-all-the-attention-the-damage-being-do.50/

• No single "official source" (clinical trial, doctor, hospital, etc.) has the resources or motivation to acquire high-quality donors, so they've all been using dangerous and ineffective donors.

• You can't patent a stool donor, so it appears that everyone with money and a financial motive has decided that it's too financially risky to undertake.

• A patient analyzed the situation and took it into their own hands to work to find high-quality donors. They've now screened over 1.2 million people worldwide.

• The FDA is essentially shutting them down because the FDA classifies them as a drug manufacturer.

• This classification also prevents people in other countries from accessing their stool donors, even if the other country has not classified FMT as a drug.

• There is no FMT-specific regulation in the USA.

• The FDA is not preventing anyone from accessing this "drug". They are only preventing people from accessing safe and effective donors. FMT is already widely available from dangerous and ineffective donors. It is practiced as a sexual activity ("eating ass"), as coprophagia, and by people DIYing a "medical procedure" with whatever friend or family they can find who is willing.

• If the FDA wanted to make FMT safer, they would allow access to high-quality donors, along with other restrictions/requirements, such as requiring medical supervision, and public tracking & reporting of results to ensure informed consent.

• Other countries have declared that poop is not a drug and should not be regulated as one. And US experts have been saying the same thing. https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-mar-2024-humanmicrobes-org.303/post-1367

• In Australia, the regulatory authority gathered feedback from the public prior to making their regulations. You can read that many professionals in the field opposed regulating FMT as a drug, or even as a biologic. They opposed GMP (good manufacturing practices) requirements because they are far too onerous. They rightfully argued that excessive regulation of FMT will only make things more dangerous.

• A highly respected science journal published an article https://www.nature.com/articles/d41586-024-02212-z titled "Faecal transplants can treat some cancers — but probably won’t ever be widely used". The reasons included “difficulties recruiting donors, demanding screening requirements”. The Human Microbes project has solved this issue, and the FDA is unsolving it.

• The FDA has approved other drugs that are inherently harmful, and many of us patients are now needing FMT to reverse the damage those drugs did.

• Hundreds of millions of dollars are being wasted by being poured into "general research" via the established research system. This system is incredibly incompetent and does not contain individuals/institutions that are able and willing to take on big ideas and unique & innovative projects. FMT requires a very specific approach (https://maximiliankohler.blogspot.com/2019/12/fmt-roadmap-proposal.html) that no one in the research system has been able/willing to take on.

• As a disabled patient, with zero funding, I've already made more progress than hundreds of researchers across the globe have for the past 20-30 years, despite their support networks and funding. They continue to run useless clinical trials with low-quality donors and do not do anything innovative, such as the vital steps in the roadmap proposal.

• Even if the FDA approves the Human Microbes project, funding and partnerships will be required to run clinical trials for Step #3 in the FMT roadmap.

• The amount of attention and funding this is getting is ridiculously disproportionate to the cost of the conditions it's likely to treat.

Edited July 22Jul 22 by Otto Kretschmer

4 hours ago, Otto Kretschmer said:

I highly suggest everyone reads the content of the links included in the OP before posting: That's what @Michael Harrop expects everybody to do.

First link:

This all feels wrong. I understand getting behind an idea, but this seems like an agenda that's being pushed on us. Who cares what Michael expects everybody to do?

Seriously, this is a science discussion forum, and we tear EVERYTHING apart to get at the reasoning and meaning behind any concept. None of the comments have been off-topic, not a single one. And trying to claim the problem is our inability to understand so we must listen to Michael is loathsome to me. Make your case, spell it out, tell us what you want us to know and we can weigh in with our own knowledge, but you started off on the wrong foot by putting Michael on some kind of pedestal. I would love to learn something from this but it feels like a setup to sell a book or some gut-related products.

12 minutes ago, Phi for All said:

Seriously, this is a science discussion forum, and we tear EVERYTHING apart to get at the reasoning and meaning behind any concept. None of the comments have been off-topic, not a single one. And trying to claim the problem is our inability to understand so we must listen to Michael is loathsome to me.

What concerns me is the notion that fecal transplant is the hill he must die on. While I might agree there are research avenues there, there is also a lot of work going on on multiple approaches to gut health - probiotics, prebiotics, FODMAP intake, hormonal regulation, elemental diet, herbal antimicrobials (for SIBO, in particular), antibiotics, prokinetic agents, and meal timing, to name a few. My training was in biology with a pre-med emphasis, later bolstered by job experience and training where I worked (for five years) with a nutritionist on getting these approaches and others to clients in direct care. So I had a chuckle when Michael said people here "lack the motivation to become well-informed on this." And I suspect @CharonY is light years beyond me, on the whole microbiology and clinical side. @StringJunky also seems well informed on this sort of topic. And we have a couple dozen more members who seem able to get up to speed rapidly on health/medical topics.

How will writing letters to a Republican Congress (or even a Democrat one if ever) make any difference ?

There are quite a few well established drugs and treatments that the manufacturers have declined or ceased to make simply because it is not profitable enough.

I feel the approach of the OPs is too focussed and unjustifiably evangelistic for the actual state of current knowledge in this area. I like this area of research, which I think is still in a high state of flux. Promoting specific therapies in that environment of uncertainty is not a good idea. It looks promising, but saying that does not mean it's practically useful now.

1 hour ago, Phi for All said:

This all feels wrong. I understand getting behind an idea, but this seems like an agenda that's being pushed on us. Who cares what Michael expects everybody to do?

Seriously, this is a science discussion forum, and we tear EVERYTHING apart to get at the reasoning and meaning behind any concept. None of the comments have been off-topic, not a single one. And trying to claim the problem is our inability to understand so we must listen to Michael is loathsome to me. Make your case, spell it out, tell us what you want us to know and we can weigh in with our own knowledge, but you started off on the wrong foot by putting Michael on some kind of pedestal. I would love to learn something from this but it feels like a setup to sell a book or some gut-related products.

It's his thread, not mine. I only opened it because he asked to to since I am a more well known forum member but I planned to open it and basically GTFO afterwards. You are directing your thoughts at a wrong person.

Edited July 22Jul 22 by Otto Kretschmer

2 minutes ago, Otto Kretschmer said:

It's his thread, not mine. I only opened it because he asked to to since I am a more well known forum member. You are directing your thoughts at a wrong person.

OK, so that's a bit unorthodox, and is part of what bothers me about this. If an idea is sound, why do you need "a more well known forum member" to pave the way for it? And not to be disrespectful, but you have less than 100 posts here. You're not that much more well known, so it seems even more like you have an agenda.

What needs to happen now is for anyone proposing this appeal to spell it out, tell us why it's so important, and to do so WITHOUT TELLING US TO CHECK THE LINKS. Members should be able to participate in discussion without going offsite or clicking links or watching videos. Forcing us to do so makes it seem like you benefit somehow from the views.

54 minutes ago, Phi for All said:

OK, so that's a bit unorthodox, and is part of what bothers me about this. If an idea is sound, why do you need "a more well known forum member" to pave the way for it? And not to be disrespectful, but you have less than 100 posts here. You're not that much more well known, so it seems even more like you have an agenda.

What needs to happen now is for anyone proposing this appeal to spell it out, tell us why it's so important, and to do so WITHOUT TELLING US TO CHECK THE LINKS. Members should be able to participate in discussion without going offsite or clicking links or watching videos. Forcing us to do so makes it seem like you benefit somehow from the views.

I don't benefit, financially or otherwise.