It is just a small (12 participants) pilot trial, but it is definitely a step in the right direction. They used "FMT capsules" and that may not be the most effective method, but it seems much less invasive than colonoscopy delivery.
' All subjects sustained motor improvement with treatment in the OFF state with greatest improvement at 1 month after treatment. At 4 months, FMT had a median reduction of 37.5% in UPDRS-Motor and 41.6% in UPDRS-Total. At 4 months placebo had a median reduction 42% in UPDRS-Motor and 38% in UPDRS-Total. At 9 months the FMT group had a median reduction of 12.5% in both UPDRS-Motor and UPDRS-Total. '
I found the following quote interesting for me personally :
' One subject randomized to FMT reported less brittle fingernails and near-total and durable remission of extensive psoriasis vulgaris of >15 years. His psoriasis prior to FMT had not shown a clinical response to clobetasol topically or systemic methotrexate according to his dermatologist.'
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Yeah, that sounds a little risky without extensive donor screening and testing. The FMT capsules are so much less invasive than colonoscopy and they eliminate the potential for problems caused by the colonoscopy itself. In this study, I think they used a reduced dose compared to what they would use for C-diff. because they didn't know how the participants were going to react to the FMT.
Don't take my word for it. Do some research (FB has multiple FMT groups), but I think the reported deaths from FMT were real outliers (people that were already really really sick given some really really bad poop). I could be wrong, but it is worth researching on your own.
One participant in this study had to be removed because shortly after starting treatment it was determined that the person had metastatic cancer and it was determined that it was not due to the FMT, but a really sad way to find out, in any case. You go into the study expecting good results for your PD only to find out you have metastatic cancer!
Here is a comprehensive review: Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020 (full) sci-hub.ru/10.1111/apt.16148
"Abstract
Background: Faecal microbiota transplantation (FMT) is an effective treatment in C. difficile infection (CDI) and is currently being investigated in other diseases. There is concern around the safety of FMT and that side effects or complications may be under-reported in the medical literature.
Aim: To evaluate the safety of FMT by summarising the overall reported Adverse Events (AEs) over a 20-year period METHODS: We searched EMBASE, MEDLINE, and Cochrane Library databases, and CNKI and Wanfang Data from January 2000 to April 2020. All original studies reporting FMT-related AEs were considered for inclusion. FMT-related AEs were further classified as delivery-related or microbiota-related.
Results: Based on the inclusion criteria, 129 studies, which included 4241 patients (5688 FMT courses), were finally eligible. The most common indication for FMT was CDI. Overall, FMT-related AEs were observed in 19% of FMT procedures. The most frequently reported FMT-related AEs were diarrhoea (10%) and abdominal discomfort/pain/cramping (7%). FMT-related serious adverse events (SAEs), including infections and deaths, have been reported in 1.4% of patients who underwent FMT (0.99% microbiota-related SAEs). Four of five FMT-related deaths were reported in patients receiving FMT via the upper gastrointestinal route. Importantly, all reported FMT-related SAEs were in patients with mucosal barrier injury.
Conclusion: Most FMT-related AEs were mild or moderate and self-limiting. Although FMT appears to be highly safe, its methodology should be improved to reduce both delivery-related AEs and, microbiota-related AEs."
There is inherent risk with colonoscopy and with the nasal delivery. The crapsules seem to eliminate those risks. I think there has been a learning curve for clinicians in determining how to effectively screen donors and the technology itself advancing to remove viral and pathogenic materials through the newest version of FMT, WMT.
I think all of these steps and procedures are refining the process and steadily reducing risks to a much safer level.
One consideration about this trial is that it was started in June 2019 and ended in May 2020, so they didn't even have the two Asian studies to revue for relevant information that would have been useful for them. I don't know why their data was not released until March 2023 given the finish date that they gave which is almost a 3 year delay???
I think that is certainly a factor in why they have developed WMT as a next generation to FMT, to try and minimize any potential risks through that extensive filtering process that can be done multiple times.
"Mucosal barrier injury (MBI) occurs during periods of prolonged neutropenia in patients receiving cytotoxic chemotherapy for hematologic malignancies. This can lead to laboratory-confirmed bloodstream infections (LCBIs) and subsequent complications, including sepsis, organ failure, and possible death." Jan 8, 2020
Well, the data from this FMT study seems only sufficient to warrant another larger trial of longer duration and higher dosage. There were 7 FMT and 4 placebo participants, making this study hard to draw meaningful conclusions from.
Both the FMT and placebo groups showed significant improvement at one month after finishing the 3 month treatment course and the placebo group seemed to fair slightly better at that time point.
This study differed from the Asian studies I had previously discussed on the forum in that the current study group received FMT capsules over the 3 month treatment period while in the other two studies the participants received a one time transplant of larger proportion when compared to the individual doses used in this study. The FMT capsules seem to be a much less invasive approach, but the Asian studies derived greater benefit from colonoscopy delivery as reflected in their data, but this would have to be weighed against the cautionary dosing used in this study.
This study used 3 highly screened donors to supply the active component for the crapsules.
The treatment increased bacteria that are known to have healthful effects while reducing some known pathogenic bacteria.
They used lower treatment dosing than typically used in C-diff studies because they gave a total of 24 doses and had no history to determine how people with PD would react. As expected, gastro issues were the side effects noted, but nobody dropped out due to the gastro issues which were described as mild to moderate and included gas, constipation, diarrhea and abdominal pain or discomfort and these occurred in both the placebo and FMT groups. Constipation did improve in the FMT group and that was one of the objectives that the research team was looking for.
Overall, it is a first step in a good direction and tends to confirm the results of the Asian studies and further confirms that the FMT capsule approach is a viable means of FMT delivery, but optimal dosing remains to be defined in other studies.
Here is a relevant quote from the study that gives an idea of the results obtained and patients subjective results seemed to be greater than test score results :
' All subjects sustained motor improvement with treatment in the OFF state with greatest improvement at 1 month after treatment. At 4 months, FMT had a median reduction of 37.5% in UPDRS-Motor and 41.6% in UPDRS-Total. At 4 months placebo had a median reduction 42% in UPDRS-Motor and 38% in UPDRS-Total. At 9 months the FMT group had a median reduction of 12.5% in both UPDRS-Motor and UPDRS-Total. '
A pertinent reminder of the placebo effect in PD. I'm a great believer in poop. I launched my membership of this group with poop. I even named myself after it. But whilst the microbiome is evidently heavily involved in the disease process it doesn't yet follow that an effective intervention has been developed.It's a start. But a very small and somewhat disappointing start.
I'm really grateful you're keeping up with this and sharing what you find out; I know you're thoughtful and meticulous in your research.
Personally I would be willing to go the DIY route but have no effective way to ensure I would be getting (pardon my street vernacular) 'good shit.'
To tell the truth, I'm not sure any form of screening will be adequate, because the human microbiome contains viruses. More and more cancers are being recognized as the direct, or indirect but predictable, result of one or more viruses. Saying Yes to FMT that uses the donor's intact microbiome profile means possibly saying Yes to an oncogenic virus.
Don't get me wrong; I'm delighted to know somebody's doing FMT trials in the U.S., and I'd sign up to have an FMT treatment tomorrow. For me, the risk would be worth the return. Breast cancer took my right breast, but I'd give my left breast to be rid of Parkinson 's.
I found these two articles about cancer and viruses (links below) at PubMed, and there are many more. Search on 'oncogenic viruses' or 'cancer and viruses' for a start.
One thing I understand about cancer is it is far too complicated for me to truly understand all of its mechanisms and interactions so I take high dose melatonin because it inhibits most forms of cancer via at least 6 methods of action and that is also one of the reasons I take berberine because of its multiple effects against many forms of cancer including glioblastoma. These are practical steps that I think I can take to protect and improve my health. The studies between these two for cancer are pretty impressive, at least to me, and they both help improve the gut microbiome in different ways while fending off CVD, the number one cause of death in the world.
I was comparing this study to the two Asian studies which used one single dose of FMT delivered via colonoscopy whereas this study used a total of 24 single doses delivered via crapsules at a dose that was very likely not optimal. The Asian studies showed a significantly better response with their single dose. The crapsule dosing was probably a bit low.
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