The Helsinki FMT/PD study results were done last August, but the release was delayed to meet publishing requirements. Those results were released today and from my point of view, the placebo group seemed to do as well or better than the FMT group, which is very disappointing. These are the worst results I have seen from any of the FMT/PD studies so far. Here is the link to the abstract as the full study is a pay or rent per view:
Importance: Dysbiosis has been robustly demonstrated in Parkinson disease (PD), and fecal microbiota transplantation (FMT) has shown promising effects in preclinical PD models.
Objective: To assess the safety and symptomatic efficacy of colonic single-dose anaerobically prepared FMT.
Design, setting, and participants: This was a double-blind, placebo-controlled, randomized clinical trial conducted between November 2020 and June 2023 with a follow-up period of 12 months at 4 hospitals in Finland. Patients with PD aged 35 to 75 years in Hoehn & Yahr stage 1-3 with a mild to moderate symptom burden and dysbiosis of fecal microbiota were included. Of 229 patients screened, 48 were randomized and 47 received the intervention. One patient discontinued due to worsening of PD symptoms. Two further patients were excluded before analysis and 45 were included in the intention-to-treat analysis.
Intervention: Participants were randomized in a 2:1 ratio to receive FMT or placebo via colonoscopy.
Main outcomes and measures: The primary end point was the change of Movement Disorder Society Unified Parkinson's Disease Rating Scale parts I-III (part III off medication) at 6 months. Safety was assessed by recording adverse events (AEs).
Results: The median (IQR) age was 65 (52.5-70.0) years in the placebo group and 66 (59.25-69.75) years in the FMT group; 9 (60.0%) and 16 (53.3%) patients were male in the placebo group and the FMT group, respectively. The primary outcome did not differ between the groups (0.97 points, 95% CI, -5.10 to 7.03, P = .75). Gastrointestinal AEs were more frequent in the FMT group (16 [53%] vs 1 [7%]; P = .003). Secondary outcomes and post hoc analyses showed stronger increase of dopaminergic medication and improvement of certain motor and nonmotor outcomes in the placebo group. Microbiota changes were more pronounced after FMT but differed by donor. Nevertheless, dysbiosis status was reversed more frequently in the placebo group.
Conclusions and relevance: FMT was safe but did not offer clinically meaningful improvements. Further studies-for example, through modified FMT approaches or bowel cleansing-are warranted regarding the specific impact of donor microbiota composition and dysbiosis conversion on motor and nonmotor outcomes as well as medication needs in PD.
Unfortunately I do not have access to the full study so I don't even know what type of FMT they used. No access to the actual study details to find out how the study was conducted, number of FMT implants used, FMT delivery method, antibiotic use or donor selection criteria etc.
Without that data, the study is currently useless to me.
The thing is Art, if the method of delivery causes anxiety and possibly pain, and certainly discomfort ... for someone already suffering those issues from PD, and someone whose nervous system is already over burdened, what positive result can they expect? When we separate all those issues from the physical, and judge only based on physical outcomes, we miss an entire world of influence and therefore possibility. My opinion .. based on what little I have learned in my short 59 years in a body.
Some of the studies have used various delivery methods such as nasal delivery, enema delivery and freeze dried capsules and colonoscopy delivery, all of which showed some benefit. I wrote a little about these here :
What is odd to me about this trial is it is the only PD one I have seen which showed no apparent benefit. That is not at all in line with previous studies and raises questions about this study imo.
So the capsules are taken orally then? One of the things I am trying to wrap my head around is the claim that a course of antibiotics is necessary, when in all likelihood it was antibiotics that caused the harm to begin with. I would not submit to the antibiotics. So there is no way to have this done in the US then? Maybe I will find this Dr. Piper Dobner in Oregon that Ob6842 mentions in the other thread.
Yes the capsules are taken orally. The antibiotics are relatively new with FMT and their purpose is to majorly kill off the current dysbiotic gut microbiome to make it easier for the new healthful bacteria to take hold and propagate with minimal to no resistance from existing pathogenic bacteria.
It is done in the US, but it is only FDA approved for C diff and some forms of IBS that have not responded to standard treatment. If you find a doctor in the US who will use it for PD or other health issues, please post that doctor's contact info as I am sure some forum members will be interested.
I will definitely do that with that doctor's permission of course. Do they get in trouble for doing it without some kind of fda approval? I don't think the antibiotic makes sense to do even though it might make sense to the experimenters. I certainly would not expose my body to more antibiotics, especially if I was required to first try that to address my issues. So it seems I am not likely to find a way to have this procedure. I'm waiting to see a gastroenterologist in september ... oy
Well done for publishing a disappointment and not hiding. I think this result confirms my primary reservation about excessive enthusiasm for this therapy.
I think the concept has great potential, but it needs to be developed, refined , tested and regulated. Shoving in any old poo any old how may not provide benefits and may risk harm. It's a shame we don't have access to the full text, but it sounds like it was a single dose therapy. If you look at the procedures operated by Taymount clinic in the UK (it's a 10 day, 10 implant program) - this trial summary doesn't specify bowel cleansing, donor screening, or number of implantations - all of which may affect outcomes
My other concern, given the cost of treatment in the UK, including accomodation and time away from work, is the horse / cart one. What causes the gut disbiosis and why won't it recurr (or "how frequently would an effective therapy be required if it is not a one-off treatment")
As for colonoscopy being invasive, it's not that invasive, and it is the origin of the success. People have DBS and FUS , which are seriously , big-time, invasive, but that doesn't prevent them being effective
Imo, a colonoscopy is an invasive procedure and my preference would be to avoid it if at all possible because of the potential for serious complications as discussed here :
There are a number of things I'd like to know about this study, but this especially; what was done dietarily (if anything) to ensure the success of the transplant? After all, diet probably contributed to the dysbiosis that was present in the first place.
nature.com/articles/s41531-..."One implication of our findings is that the previously reported microbiome associations with PD may have been due, at least partially, to dietary differences between PD patients and control subjects."
If conditions in the gut stay the same after transplantation, it stands to reason the dysbiosis would recur. Also, evidence is accumulating that a dearth of short-chain fatty acid producing bacteria is a major contributor to PD. Here's just one of many papers on the subject;
ncbi.nlm.nih.gov/pmc/articl..."Decreases of short-chain fatty acid-producing genera, Fusicatenibacter, Faecalibacterium, and Blautia, as well as an increase of mucin-degrading genus Akkermansia, predicted accelerated disease progression."
What, in the present study, was done to encourage the proliferation of these beneficial bacteria and inhibit the proliferation of Akkermansia and possibly Desulfovibrio? Surely one treatment alone could not be expected to overcome decades of dysbiosis? If I was getting FMT, I'd want a really thorough bowel cleanse AND antibiotics AND multiple treatments....... to give the new microbiome a fighting chance!
I don't think any researchers are going into these trials expecting that "FMT will permanently enhance the gut microbiome", but previous FMT/PD trials have shown efficacy exceeding a year, with or without the use of antibiotics. For C diff., which is the approved use by the FDA, FMT has lasted to the 4 to 8 year range as discussed here :
' The long-term efficacy (48-96 months) of FMT for RCDI appears to be durable even after non-CDI antibiotic use. Thirty percent had improvement of their pre-existing medical conditions following FMT; 73.9% reported "much better" overall health following FMT. '
The above quote suggests how many other uses for FMT have been discovered through benefit to people with C diff. who also happened to have other diseases or health issues that also benefited from the FMT treatment.
If it was a once a year treatment, that seems quite tolerable, especially if it only required taking the freeze dried FMT capsules once or twice a year, which have shown significantly better efficacy than this latest Helsinki trial and on par with other trials utilizing colonoscopy delivery. I don't think it is a reasonable expectation that FMT transplants will last indefinitely, unless you happen to be taking the capsules on a regular basis from the same donor or donors.
While FMT has been well tested for C diff. and less so for IBS-d, such testing is continuing, while FMT has relatively minimal testing in other health conditions.
Supposedly, FMT is one of the first steps in ultimately creating a super synbiotic of sorts with all of the needed health promoting bacteria and prebiotics in possibly capsule, drink or food forms in order to restore proper gut homeostasis, but that is many many years away from being a reality, assuming that it is ever realized at all.
It's a very small study and we don't know even how many were in advance stages of PD versus earlier stages... Unless that's of course disclosed in the selection criteria in the study, I'm not going to pay for the access so maybe somebody else can say.
Here is a quote from the abstract of a very basic patient description :
' Patients with PD aged 35 to 75 years in Hoehn & Yahr stage 1-3 with a mild to moderate symptom burden and dysbiosis of fecal microbiota were included. '
This does not sound like advanced stage PD and advanced stage is often an exclusion criteria in these small studies.
It is a small study, but in terms of FMT/PD studies to date, it is actually one of the larger studies.
I wouldn't pay to see these trial results because of the fact that they didn't mention anything positive in the treatment group and this is the only FMT/PD trial that found those results. The other trials I have seen had at least minimal positive results. That makes me think there may have been something wrong with their study design, donor selection or execution to name a few possibilities. Had there been other similar studies showing similar results, I might think that this is the norm.
Never mind! If you were to walk, as fast as you can, for only one hour, every second day, you will be PD symptom-free within a year.
I was diagnosed in 1992 and by 1996 I was symptom-free and, have remained so, right up to today, although I don't walk quite as fast and, I now use a walker!
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
Thumbs up for Nilotinib - Phase II Trials
Palmitoylethanolamide - Luteolin: Kind of Interesting
How many know that H2, hydrogen water has positive effects for those with Parkinsons? I didn't know.
