SFBayFMT5

That makes perfect sense thanks.

That sounds odd to me... so using it for a condition that it's already been approved for (i.e. for its "intended use") actually requires more paperwork than using it off-label for another condition?? Or are you saying that in order to GET it approved for a new use (such that, from then on, such use is no longer considered "off label") requires an IND?

How is requiring an IND filing at all similar to regular off-label use? Using regular drugs off-label just means that a medical professional believes that the drug could be helpful for a condition other than what the FDA approved the drug for--it doesn't require any further FDA approval of the use. So if Rebyota is approved in such a way that limits it only to one particular use without filing additional paperwork with the FDA, then that is a very UNusual type of "conditional approval".

It is banned in the sense that any doctors who would use it off-label, outside of a clinical trial, are risking sanction from medical boards. Clinics that provide FMT are operating in a gray zone where they could be shut down any time--it's not just that the patients have to pay out of pocket (which they do).

The ammonium acetate is water soluble and easily separated from the 5-formylsalicylic acid reactant and the SANA product using an organic/aqueous extraction, done at acidic pH to be sure that the salicylic acid derivatives are mostly protonated, in which case they are much more soluble in the organic phase (especially the product, which has a significantly lower % polar surface area). It seems to me that the difficult part is separating the SANA product from any unreacted 5-formylsalicylic acid, as these are likely to have a similar pKa. The electron-withdrawing effect of the nitro group on the conjugated system would be expected to lower the pKa of the former slightly relative to the latter, but this effect may well be small given how far away it is from the carboxyl and the fact that the two are not in direct resonance--quite possibly too small to find a pH where the product is >90% ionized yet <1% of the reactant is.

He IS "sentenced to a slow death" in many ways without access to this treatment, as am I. We would all like to have more access to this treatment, due to the success we have had in the past. And unfortunately, it's illegal for gastroenterologists in the United States to offer this treatment for anything other than C. diff. Laws in the rest of the world vary from banned like the US--for instance in Canada--to not forbidden but not officially legal either, like in Asturias, where their manufacturing process has legal oversight just like any other supplement or drug manufacturer but there is no official sanctioning of the product itself, to legal and regulated, as in Australia. That's the situation we're in. One person on another forum compared the situation to medical cannabis in the early days--patients reporting significant benefits but no official channels to obtain it. And you had evangelists there too, people claiming it was God's medicine that would cure all disease and create world peace on top of it. The more underground a product is driven, the more it rewards people for being unscrupulous rather than honest. Unfortunately even the doctors don't have much knowledge of this except for in the case of C. diff. This requires trial and error, that's why there's a thriving web of forums for people to review different donors for different diseases (not just Harrop's product). Some people use family members or partners--there's a famous case of an Australian man who cured his bipolar disorder by using his girlfriend or wife, and another case from somewhere (may have also been Australia) of a woman with bipolar who was cured using her boyfriend or husband. However, others find that non-family members work better due to the lack of shared genetic vulnerability. So yes, it's disingenuous for ANYONE (even a doctor) to claim that this is a "solved problem"--this is a case of "the more data the better". And Harrop has been at the forefront of promoting this kind of data sharing, even if he then hallucinates that the data shows something that it doesn't (and of course this doesn't make making unsupported claims ethical). A researcher at Arizona State has been doing this as a clinical trial for people with autism. These trials are VERY difficult to get into--I contacted them and there was no space left. And who knows when their treatment will become available. And then you still have the question of, what happens if you have a patient who doesn't get better with a particular donor/method who might improve dramatically with a different one? It seems I lucked out by the first FMT I got for C. diff being exactly what I needed for my other conditions as well, whether it's the donor that's to credit or the pre-treatment or something else--we don't want the treatment as a whole to flounder if people don't get an effective donor or supplier the first time. One of the donors I tried DID make me worse--luckily it was my fourth and not my first so I knew it was just that donor.

Ok.... so here's in a nutshell the history of Harrop and FMT: -He developed IBS and ME/CFS (I think sometime in the early 2010s but I'm not sure) -He did the standard treatment with Xifaxan (rifaximin) for IBS, which actually made his IBS worse if anything. He also tried several probiotics, one in particular of which was soil-based and caused considerable, permanent worsening. -Realizing that the only option that remained to fix his microbiome was FMT, he began looking for sources. This was around the year 2016. -Somewhere around that time, he started working for Microbioma, a provider of FMTs based in Asturias, Spain (though he was in the US). He believed that their donor screening wasn't rigorous enough, and also had some sort of disagreement with the owner over pricing and or/salary, if what I've heard is true, so he left them without having ever tried their product (which he could have done for free as an employee of theirs). - He asked a healthy acquaintance to be his first donor--an active teenager living somewhere near him. Her stool caused a dramatic improvement; however, she became unwilling to donate partway through the treatment, requiring him to use another donor, who wasn't effective. -Three donors later, he found another effective one, a college-age female athlete. However again, this donor backed out partway through the treatment. -He has tried at least 10 donors since then, and only two provided significant improvement. He was able to use these two donors for an extended period of time, and yet they were not as effective as the 1st and 4th were after just one dose. -Through his experiences at Microbioma and testing his own donors, Harrop has concluded that a number of important factors have been overlooked by all other FMT providers and organizers of clinical trials. Foremost among these is stool consistency, which he has deduced must be uniformly firm for an effective donor (i.e. not fluctuating). He also believes that antibiotic use needs to be excluded for longer into the past than most screening procedures for FMT do. He has noticed differences even between different stools from the same donor, though it's unclear how big a difference this really makes, as it was clearly insufficient to make later donors effective in the way that #1 and #4 were. -Over the years, Harrop has interviewed many thousands of donors (he claims "a million", but nobody knows how far most of these got, i.e. if many were just people he emailed and got no response from). Despite this, he claims that there were characteristics shared by the 1st and 4th donor that have been absent in all subsequent prospective donors. This has understandably led to incredible frustration. -During this time, he was selling FMTs to other patients. The way this worked was by acting as a liaison between the patients and the donors--he did not prepare the FMTs himself. Due to lack of funds (he's disabled and poor), he used the meager profit from this to help defray the cost of doing bloodwork and stool testing for new donors. Even so, despite having a list with tens of theoretically available donors, at any one time only 2-3 of these were actually tested and thus safe to order from. Importantly, those two donors who were actually curative for Harrop were never available to his customers, and so we have no data on how well they would have worked for anyone else. None. -To top it off, the final straw was that in the first half of 2025, the FDA demanded that he shut down. That is what he's protesting at this point. Ok so the good: Harrop put in a tremendous amount of work, while disabled himself, to recruit and screen donors and test them himself in order to identify criteria that made a difference, and made an effort to compile a spreadsheet of recipients' results from the donors whose stool he sold. This is very different from, e.g. OpenBiome, where no patients have a clue if they received the same donor as another patient who got a certain benefit or side effect. The bad: The first part of this is not Harrop's fault--the fact that he was unable to find another donor like those two who helped him early on, even before the FDA shut him down. But it means that the FDA allowing him to operate again wouldn't really solve the problem in and of itself. Something that IS in Harrop's control, though, is that nobody really knows what it would entail for another donor to be "like the effective ones". Whether Harrop is withholding the details as a sort of trade secret of his, or whether he doesn't actually have a clear idea himself, nobody can realistically assess the rarity of such donors in the population without him spelling out what exactly the criteria are. While he definitely could use help, sometimes he comes across as "just give me enough money and I'll find one", which understandably nobody is likely to respond to. A second outpoint is the way he paints his organization. He has on several occasions claimed that he has "the most effective FMT donors" of all the sources available. However, there is no tidal wave of people saying that they tried other providers without improving, and then found Harrop's business and all got cured--not even on Harrop's own forum, let alone any other forums out there. And Harrop himself has only tried one other provider--a clinic in Florida that ended up having one of the later two donors who came closest to replicating his #1 and #4. Among people I know about (including myself) who HAVE been able to compare Harrop's FMTs with other suppliers' FMTs by firsthand experience, we have found that his FMTs are roughly comparable to what you get elsewhere on average (with, as already said, OpenBiome standing out as the clear winner so far for me). In many ways that's remarkable given that he was operating out of a P.O. box with no lab space, but still, it's important that he doesn't imply that his business should receive special treatment, which some of his early writings to Congress bordered on doing. Harrop has even claimed at times to be "the world expert on FMT" or to have "solved the donor selection problem". The latter overlooks the fact that even if he were 100% correct in judging who would be an effective donor for himself, and even if that translated into effectiveness for other patients (which, as I said, would need to be taken completely on faith, as neither of his curative donors were ever available to anyone else to test), he has NOT solved the problem of how to FIND these donors. Most importantly, this kind of overclaiming is completely unnecessary, as it is an undisputed fact that there are patients like myself, with a history of dramatic response to a FMT, who have no way to re-treat with the same donor, as there is no compassionate use clause or similar to allow this. That alone means that there is need for change in this area--the question is how people like Harrop need to communicate the need to those in their power to change things.

He's far from good at being concise and to the point, as you will quickly learn if you read any of the wiki on the human microbiome forum (all of which he wrote). He has a write-up of detailed reports of his results with all the donors he's tried--over ten pages of information--and even after reading it closely, I couldn't have told which were the donors who most helped him without asking him directly. And you can't even get to the actual case reports without scrolling through over a page of rants about the current state of college athletics, political candidates, and such. Granted, one of the consequences I've experienced due to a disrupted microbiome is an ADHD-like extreme difficulty with focusing at times. I'm wondering if he has some of this. Possibly because some others have mentioned about this to him, in this thread he seems to have been significantly more committed to staying brief. Unfortunately, it seems he is doing this by leaving out key information/details (like why and how he got into this in the first place, and what experience he has that backs up what he says), rather than giving JUST that information without so much "fluff". His heart is definitely in the right place, wanting to get FMT to everyone who could benefit from it--but he needs help communicating effectively with politicians, philanthropists, and even possibly with potential donors (the first donor who most helped him was a real-life acquaintance--he later switched to social media and the quality of donors he attracts there has been lower). Not only is he a lone voice, as I said above, communication is not his strong point. Unfortunately I'm not the person to do so--not only am I also sick, I'm on the autism spectrum and therefore building social bridges is not my strength. I can interpret the biochemistry and microbiology of scientific papers, but winning over supporters is not something I'm adept at. It's not like there are many options for those of us with microbiome problems, who have realized that conventional medicine can't help us but FMT can. Yeah definitely NOT an alt account lol. We tolerate each other passably on the other forum, that's about it. I go there to read other patients' experiences and occasionally to see if any interesting papers have been linked to. And Kretschmer is correct, he doesn't offer anything for sale in that other forum. It WAS connected with Harrop's business in that he had a special section of recipient reports just for customers of his business, but anyone can (and many have, including myself) posted experience reports from other providers in the general report section of the forum.

Just as a minor follow-up to the above, where I wrote: good donor criteria will obviously be something that gets refined as more work is done (and more people report their experiences with various donors; that's one thing Harrop has been VERY good about doing--maintaining a community for recipient feedback and a spreadsheet of recipient results). A hypothesis that cannot be adjusted in light of new data is not science, it's faith. However, that being said, when attributing failures of previous studies to "low donor quality", it is important to have a working definition of "poor donor quality" that is clearly laid out enough, such that a researcher who took part in one of those studies can actually independently assess where they stand along this "axis" without needing to leave everything up to the subjective judgment of the person (e.g. Harrop) doing the alleging. FWIW, in my particular case I suspect it was a small amount of cannabis use at about the 6-week mark. It was a small amount, less than amounts I had previously consumed on many occasions without noticeable long-term effects, though it was a new strain that had been given to me by another Lyme patient who said that it had been specially bred to be helpful with neuropathy by a grower he knows, and said Lyme patient friend said it was unusually potent for him. I can't be sure this was the trigger, but the chronic diarrhea that had been completely gone ever since the very first post-FMT bowel movement suddenly came back about an hour after this. The other gains started reversing 4 days later, despite me having continued to improve for 6 weeks straight after the FMT (with no further treatment). In fact, my greatest gains were at the end of the 5th week. So I was certainly in a vulnerable state of flux, and immune cells do express cannabinoid receptors so it's plausible. It will take finding another donor who gives me that sort of gain again to test whether it lasts longer if I DON'T do this. In the case of Harrop, unlike myself who received everything as one bolus treatment, he did continuous treatment and the donors who were effective for him stopped donating a short while into the treatment, requiring he switch donors... that's when he relapsed. Absolutely. It is my opinion that Harrop puts too much stock in the idea of universal donors, to the point where he ignores potentially meaningful information about different clusters of recipients. For example recipient sex... there are a number of people who reported on a patient forum getting worse (i.e. picking up new conditions) after FMTs from OpenBiome, and interestingly, all of the ones we know about were women. It was either 5 or 6 recipients, so that's a 1/32 to a 1/64 probability of happening by chance. It's possible that some were encouraged to report these by seeing the experiences of the other women, in a way that wouldn't have happened had they been male, but it's potentially something to actually look into. Especially considering that I'm male myself, and there is one other patient I know of who had success with OpenBiome but no other source that he tried--he's male also. Given that with OpenBiome nobody knows who got which donor (this is kept strictly confidential) and these experiences spanned years, it seems more likely that if there IS a recipient sex effect that it is an to do with their methods (e.g. the type of filtration) as opposed to a donor issue. Harrop seems totally uninterested in these types of correlations, he's obviously trying to come up with one donor quality scale for everyone, whether they have Crohn's disease, diabetes, or autism, which seems as though it's unlikely to pan out. He's posting all the experiences anyone has shared across the web publicly though, so anyone else can come to their own conclusions. Of course this isn't a controlled experiment--nobody is randomizing patients to donors (or if they ARE, like OpenBiome, the recipients cannot report it). If there's any hint of clustering I pick up in patterns of response to gut treatments (aside from things like the OpenBiome adverse events being so far unique to female recipients), it relates to people who improve on high-fiber plant-based diets versus those whose symptoms are aggravated by these, but it's too early to tell how robust this separation is.

He had great but temporary success with two donors early in his journey of FMT trials. More recent donors he has found have been less effective, which he attributes to poor donor quality. A large part of donor quality in his experience is stool type (i.e. #4 on the Bristol scale), however this by itself is apparently not sufficient. He can elaborate on the other criteria more if he likes--I've been trying to get him to pin these down better because as you have observed, these seem like a "moving target" that would be difficult for a study coordinator to outline in a proposal. I also had dramatic--albeit temporary--success with a FMT, from OpenBiome. The purpose was ostensibly C. diff, as I had recurrent C. diff at the time--but the most dramatic benefits were for things that had been going on MUCH longer than the C. diff. It greatly improved a whole constellation of neuropsychiatric and digestive issues that were all part of "post-Lyme disease"--I.e. that I'd attributed to continuing inflammation following treatment for a (laboratory confirmed by the ELISA/Western blot combo) case of Lyme disease, but that appear to have actually resulted from a disrupted gut microbiome. Others who have been through the grueling Lyme antibiotic regimen (after seeing doctors, out of desperation, who promote treatment much longer than is wise) have reported similar abrupt gains from FMT, it's not just me. I have had SOME success with other providers (one in the Netherlands, as well as Harrop's own business when it was in operation) but not nearly to the level of OpenBiome. I'm very eager to figure out what was the difference--variables that MIGHT be at play were finer filtration at OpenBiome (330 um mesh size, as per here: https://pmc.ncbi.nlm.nih.gov/articles/PMC8082449/) compared to the others (kitchen strainer or whole stool), as well as vancomycin pre-treatment for the OpenBiome FMT (which was necessary given the C. diff). The ASU study used vancomycin pre-treatment and used standardized stool provided by the successor to OpenBiome, which likely used similar methods.