FMT for treating dysbiosis triggered by probiotics: Experiences? | CDD (Center for Digestive Diseases) and FMT safety discussion Sources

Anon24 · Sep 14, 2024

Hello,

Because I am considering a treatment with FMT, I am interested in (anonymous) anecdotes from/about people who have experienced something like the following:
Took probiotics, and then developed intense brain fog and fatigue and some gut symptoms.
Took antibiotics and got better.
Then the problem came back. (This part happened to me.)
Then tried FMT. (This is what the gastroenterologist says that he might offer me. In Australia.)

Have you experienced this or heard about experiences like this online?

Was it capsule FMT, or delivery to the duodenum, or delivery to the colon by colonoscopy, or an enema?

Did the person get better?

Hearing some real examples would be very useful to me because in the research literature I can only find loosely related examples, but not any data on this exact problem and treatment.

Obviously I will ask the gastroenterologist who suggested FMT about what his experience has been with previous patients, but I don't think he has used this exact treatment before for someone with this exact problem / history. He says that it has been useful for some similar / related problems.

Any experiences that you can contribute would be a great help to me.

Regards,

Anon24

Michael Harrop · Sep 14, 2024

I developed a variety of severe detriments from a soil-based probiotic (Prescript-Assist): https://archive.today/lC93l

I've done FMTs from 16+ donors (upper and lower routes) and haven't reversed all/most of the detriments. But that probiotic wasn't the only thing to harm me. Prior to it, I was severely harmed from Rifaximin, and possibly metronidazole. After the probiotic and antibiotics, I also used a dangerous FMT donor out of desperation and got worse as well. So I've taken a lot of damage from multiple sources.

At certain times, some antibiotics seemed to be helpful, but they're not a solution. They do not restore eubiosis. They only temporarily suppress some of the problematic microbes.

Anon24 said:
FMT. (This is what the gastroenterologist says that he might offer me. In Australia.)

I would recommend against that. Their donor quality is poor so the chances that you will get worse and/or develop new conditions are high. Read these:

Anon24 said:
I will ask the gastroenterologist who suggested FMT about what his experience has been with previous patients

You can't take their word for it. The tracking & reporting of results at nearly all sources of FMT is extremely poor. Without public, systematic tracking & reporting of results, such as is shown in this spreadsheet https://docs.google.com/spreadsheets/d/1E9TFLqh9I2ZZhDSvGljyhukU-71fFMmJ, you cannot properly judge their results, and thus you will be taking a huge risk.

FMT is highly donor-quality-dependent, and even different recipients with the same problem will have varying results from the same donor.

Anon24 · Sep 27, 2024

Hi Michael, (CC: The whole internet)

I found the data in your spreadsheet interesting, and I think the limitation is that the substantial heterogeneity in the data makes it difficult to draw conclusions. (These people had widely varying symptoms, for example.)

Also, I'm inferring that these were DIY procedures where there was not a lyophilization process for the stool before it went into the capsules. My perception from the (admittedly small) research literature was that the studies which found the capsules useful were the ones which had used a lyophilization procedure. (For example, Dr Xu in China found capsules useful for SIBO in 2021.)

I have actually been impressed with the quality of research that has come out of Sydney. (For example, this study by Dr Haifer is quite recent and although it is about a condition which I do not have, it does say a lot about the safety of the CDD's FMT capsules and about their effect on the stool microbiomes of the participants: 10.1016/S2468-1253(21)00400-3 ) By the way, they did have some interesting findings about the donor-dependent effects that you alluded to.

Both the research literature and the advice from the nurse have given me a good sense of how they screen the donors in Sydney. I can see new ideas for being even more selective (for the sake of efficacy, not just safety), but since only 1 person in 50 makes the cut (according to the nurse), I don't know how practical that is for them. Hopefully one day they will optimise donor selection based on stool microbiome composition, not just phenotype characteristics (if I've understood their process correctly).

Also, Australia's Therapeutic Goods Administration has shut down the providers who were not adequately rigorous. There's no way that I would go with a product that did not have their stamp of approval. The CDD's product is approved (and described) here: https://www.tga.gov.au/resources/prescription-medicines-registrations/faecal-microbiota-transplant-fmt-centre-digestive-diseases-pty-ltd
They can only be administered under the supervision of a gastroenterologist, of course.

For the record, I have ordered FMT capsules from the Centre for Digestive Diseases (CDD) in Sydney, which are on their way to me now. Maybe I might anonymously post about how it goes, for the benefit of future patients. I gather that it has only been within the last 3 months that patients like me (i.e. no C Diff and not participating in a formal study) have been offered these capsules in Australia.

Michael Harrop · Sep 27, 2024

Anon24 said:
Also, I'm inferring that these were DIY procedures where there was not a lyophilization process for the stool before it went into the capsules. My perception from the (admittedly small) research literature was that the studies which found the capsules useful were the ones which had used a lyophilization procedure. (For example, Dr Xu in China found capsules useful for SIBO in 2021.)

Lyophilization has nothing to do with increasing efficacy. If anything, it decreases it. https://humanmicrobiome.info/fmt/?h=lyophilization#freezing

Anon24 said:
I have actually been impressed with the quality of research that has come out of Sydney

The study you refer to:
Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial (2022, n=35)

It's closed access so it can't be fully assessed. From the abstract:

At week 8, eight (53%) of 15 patients in the FMT group were in corticosteroid-free clinical remission with endoscopic remission or response, as were three (15%) of 20 patients in the placebo group

Adverse events occurred in 10 (67%) patients in the FMT group and 17 (85%) of those in the placebo group during the 8-week induction period, and were generally mild and self-limiting gastrointestinal complaints. Serious adverse events included worsening ulcerative colitis (two in the FMT group, one in the placebo group) and per-rectal bleeding (one in the placebo group).

Antibiotics followed by orally administered FMT

There's no access to any information about the donor or how they tracked adverse events. Even if you think those are good odds and went to the same hospital to get the FMT there is no guarantee that you'd get the same donor used in the study. So getting FMT from a location like that is still a black box and rolling the dice.

Anon24 said:
only 1 person in 50 makes the cut (according to the nurse)

That's a horrible percentage. Openbiome would accept 3% and there were major deficiencies with their donors and numerous reports of people getting worse and developing new problems. The same is true for a clinic that accepted 3 out of 700. There are even people who got worse from my 1 in 25,000 donor.

Anon24 said:
Also, Australia's Therapeutic Goods Administration has shut down the providers who were not adequately rigorous.

This sounds like you didn't review the links I shared. I wrote to the TGA recently, after looking over their regulations, and reading experiences from patients who had FMT done there. The TGA is absolutely not "shutting down providers who are not adequately rigorous"; the TGA's regulations enforce an ethos where it's impossible to access high-quality donors. Such donors can only be reliably available through 3rd parties that specialize in recruiting and screening huge numbers of applicants, due to how rare such donors are.

I think you're poorly informed to consider the TGA's stamp of approval as valuable for judging FMT safety or efficacy.

Here's a quote from my letter to the TGA:

There is an easy challenge that could be made prior to making any "major" changes, such as rewriting the rules to allow the use of our donors:

Simply require every source of FMT or stool donors to publicly track and report their results in the format that we do (see spreadsheet at https://www.humanmicrobes.org/orders), after educating patients that virtually any condition can be transferred from the donor, and any new or worsening condition after FMT may be attributed to the donor. Even if the donor doesn't have the specific condition themselves, transferring a dysbiotic gut microbiome can have a wide range of unpredictable consequences for the recipient. This is supported extensively throughout the literature, from case reports, and from HM's (Human Microbes) results:

https://humanmicrobiome.info/intro/ + "conditions" pages.

https://humanmicrobiome.info/fmt-questionnaire/

Everyone will then see the true quality of the donors being used. And we'll see how the outcomes of the current TGA safety measures compare to HM's. Even seemingly flawless, very impressive donors can have bad outcomes for patients; so much more so for obviously flawed, low-quality donors, which are currently the norm worldwide. Publicly tracking & reporting results is ultimately the only objective method of judging donor quality and verifying the validity of the requirements in the link below.

None of the requirements here https://www.legislation.gov.au/F2020L01011/latest/text are capable of determining or ensuring donor safety. It appears that they over-rely on less important (and overly onerous) measures because those were the only known tools available. That's not the case anymore. I have better tools.

Anon24 said:
The CDD's product is approved (and described) here:

"Described" seems overly generous. There's a sentence or two, completely non-descriptive. There's no useful information on that page as far as I can tell.

Anon24 said:
I have ordered FMT capsules from the Centre for Digestive Diseases (CDD) in Sydney, which are on their way to me now

Great. I look forward to your write up about how it goes. Unfortunately, most people don't bother to share their experiences here, or publicly at all. Many of them are nightmarish, but no one learns about it because they don't post them publicly. So people continue using the same dangerous sources of FMT and continue getting worse, and don't bother joining in efforts to acquire higher quality donors.

Anon24 · Sep 27, 2024

Actually I purchased the paper about the LOTUS study. They used special screening methods (looking at abundance of certain classes of microbes) in order to get stools that were optimal for treating ulcerative colitis. Could be why they had a much higher response rate than the last UC / FMT study. A follow-up paper suggested that evenness of the microbiome was predictive of engraftment.

When I read the details of the adverse events in the paper, it looked pretty safe to me even at these huge dosages of 24 caps/day. (Some bad things happened, but at similar rates between the treatment and control arms. Not everything that goes wrong is a result of the treatment.) I recall that Xu 2021 also found his/her lyophilised stool capsules quite safe: 10.1186/s12876-021-01630-x

The nurses at the CDD apparently say that the most common short-term side effect of the cFMT is bloating. I can accept that.

Also, that page on your website doesn't seem to mention Hamblin's 2022 study at the CDD: 10.1155/2022/6083896
He concluded that FMT at the CDD was pretty safe, and I remember thinking that the main problem which was obvious to me was just that not many patients returned the questionnaires. So the real response rate could be a bit different to what he describes. But that's for IBS patients.

Michael Harrop · Sep 27, 2024

Anon24 said:
Actually I purchased the paper about the LOTUS study. They used special screening methods (looking at abundance of certain classes of microbes) in order to get stools that were optimal for treating ulcerative colitis. Could be why they had a much higher response rate than the last UC / FMT study.

Per this Sep 2023 review:

Out of 261 patients in the FMT group, 70 achieved endoscopic remission (26.82%). In comparison, 39 out of 250 patients in the control group achieved remission (15.60%).

The study you reference has a higher percentage, but also includes "response", not just "remission":

At week 8, eight (53%) of 15 patients in the FMT group were in corticosteroid-free clinical remission with endoscopic remission or response

A Sep 2017 review of 4 trials had a 42% clinical remission https://humanmicrobiome.info/ibd/#ulcerative-colitis. So it doesn't appear that these studies are getting better results over time. There's also another study there with "one donor having 100% efficacy compared with a second donor (36% efficacy)".

From a Jun 2024 study there: "clinical response and clinical remission rates were 72.86% and 25.71%". So mixing those two gets you around 50%.

Regarding "special screening methods (looking at abundance of certain classes of microbes)", this has not worked in the studies I've seen: https://humanmicrobiome.info/fmt/#donor-selection

Anon24 said:
it looked pretty safe to me even at these huge dosages of 24 caps/day.

30 capsules was Openbiome's standard dose. Dose size has very little to do with safety. FMT is not a drug.

Safety and efficacy are almost entirely based on donor quality. All other factors appear to be relatively trivial.

Anon24 said:
I recall that Xu 2021 also found his/her lyophilised stool capsules quite safe

I addressed this in the blog links I shared. You linked to a Chinese SIBO study. I agree that the studies have concluded that FMT is safe (https://humanmicrobiome.info/fmt/#safety), regardless of the condition or method. As I laid out in the blog, I think it's largely BS. Perhaps the FDA agrees, given that they have not approved FMT for any condition.

Anon24 said:
The nurses at the CDD apparently say that the most common short-term side effect of the cFMT is bloating. I can accept that.

That sounds like a perfectly valid method of determining the safety of CDD's FMT. (this is sarcasm)

Anon24 said:
that page on your website doesn't seem to mention Hamblin's 2022 study at the CDD

I'm not sure which page you're referring to. It's an IBS study listed in the IBS section: https://humanmicrobiome.info/intro/#ibs

If you mean the CDD section here https://humanmicrobiome.info/where-to-get-fmt/#center-for-digestive-diseases-cdd-au, I link to their website, where presumably they would keep a list of all the studies they conduct. Yet at the bottom of their page, the papers they reference are done by other groups.

But there's also another Orcid link there to all their published papers.

I'll update the CDD section to include the fact that they're offering capsules now as well, per the link you shared.

Angie · Sep 29, 2024

Anon24 said:
Hello,

Because I am considering a treatment with FMT, I am interested in (anonymous) anecdotes from/about people who have experienced something like the following:
Took probiotics, and then developed intense brain fog and fatigue and some gut symptoms.
Took antibiotics and got better.
Then the problem came back. (This part happened to me.)
Then tried FMT. (This is what the gastroenterologist says that he might offer me. In Australia.)

Have you experienced this or heard about experiences like this online?

Was it capsule FMT, or delivery to the duodenum, or delivery to the colon by colonoscopy, or an enema?

Did the person get better?

Hearing some real examples would be very useful to me because in the research literature I can only find loosely related examples, but not any data on this exact problem and treatment.

Obviously I will ask the gastroenterologist who suggested FMT about what his experience has been with previous patients, but I don't think he has used this exact treatment before for someone with this exact problem / history. He says that it has been useful for some similar / related problems.

Any experiences that you can contribute would be a great help to me.

Regards,

Anon24

Hoe did you end up, I had FMT from CDD and I'm actually worse now. Their level of care is zero.

Michael Harrop · Oct 2, 2024

Angie posted about her experience to a private group and I invited her to post a detailed report to the clinics subforum. It is useful for everyone to be able to learn from such reports.

Anon24 · Oct 6, 2024

Angie said:
Hoe did you end up, I had FMT from CDD and I'm actually worse now. Their level of care is zero.

Hey Angie,

I found too that they can be a little bit difficult to deal with, and I think that most high ranking doctors are a bit callous. But I stuck with them because I knew that they do a a lot of serious R&D and so they have some treatments which aren't available elsewhere.

Actually, I started the course of capsule FMT ('crapsules' / poo pills) on Wednesday afternoon and I felt amazing on Thursday evening (after 6 caps total) because the brain fog and fatigue had cleared up. And I'm still feeling amazing compared to how I was before I started the course. (Seems like the side effect for me is a bit of extra burping. Not finished the course yet.)

(It has not fixed the mild IBS symptoms that I had had before the nasty dysbiosis started two years ago, but I'm open to the possibility that it might because that can be a delayed effect.)

One factor to consider is that the capsule therapy targets the small intestine at a point upstream of where their procedure targets (only the colon). So I wouldn't be surprised if people whose problems involve the small intestine do better with the capsules than they do with the procedure. Though obviously I don't have any qualifications in this area, and I can't give medical advice.

I'm intending to also compare my stool microbiome at the one-week mark with how it was before the treatment. Would be interesting to see whether the large shift in symptoms was concurrent with a large shift in bacterial abundances.

But I'd better stop writing and take my sixth dose now.

Angie · Oct 6, 2024

Anon24 said:
Hey Angie,

I found too that they can be a little bit difficult to deal with, and I think that most high ranking doctors are a bit callous. But I stuck with them because I knew that they do a a lot of serious R&D and so they have some treatments which aren't available elsewhere.

Actually, I started the course of capsule FMT ('crapsules' / poo pills) on Wednesday afternoon and I felt amazing on Thursday evening (after 6 caps total) because the brain fog and fatigue had cleared up. And I'm still feeling amazing compared to how I was before I started the course. (Seems like the side effect for me is a bit of extra burping. Not finished the course yet.)

(It has not fixed the mild IBS symptoms that I had had before the nasty dysbiosis started two years ago, but I'm open to the possibility that it might because that can be a delayed effect.)

One factor to consider is that the capsule therapy targets the small intestine at a point upstream of where their procedure targets (only the colon). So I wouldn't be surprised if people whose problems involve the small intestine do better with the capsules than they do with the procedure. Though obviously I don't have any qualifications in this area, and I can't give medical advice.

I'm intending to also compare my stool microbiome at the one-week mark with how it was before the treatment. Would be interesting to see whether the large shift in symptoms was concurrent with a large shift in bacterial abundances.

But I'd better stop writing and take my sixth dose now.

Who is your treating Dr at CDD ?

Anon24 · Oct 7, 2024

Angie said:
Who is your treating Dr at CDD ?

Hi Angie,

Actually I prefer not to say.
But for the capsule FMT, I think that because Prof Borody developed it, they're all following his lead in the matter and so I assume that they're pretty aligned.

Anon24

Angie · Oct 7, 2024

Ok well may ask what the FMT is treating and the protocol provided for FMT please ?

Anon24 · Oct 8, 2024

Angie said:
Ok well may ask what the FMT is treating and the protocol provided for FMT please ?

It was diagnosed as a dysbiosis, with suspected d-lactic acidosis. (The biggest problems were brain fog and fatigue, which correlated with the gut symptoms.)
Treatment is daily doses of FMT capsules and I'm part-way through the course now.
I prefer not to go into more detail than that.

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