With the gut microflora (the gut-brain axis) able to affect the brain and cognition and with dysregulated gut microflora implicated in chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) – not to mention diseases like Parkinson’s and Alzheimer’s – a finding a corrective gut flora treatment might be a big deal.
So why not take up fecal matter transplants (FMT) transplants – something Chinese medicine employed almost 2,000 years ago? More recently, they’ve, after all, been successfully used to treat the very dangerous Clostridium difficile infections.
So why would they not help out ME/CFS, fibromyalgia, or irritable bowel syndrome – all disorders with gut flora issues? Laura Pace, the co-founder of the Metrodora Institute, has one reason – the difference in the flora between the bowel and the flora of the small intestine – where most of the digestion, etc. is.
Fecal matter transplants are underway, however, being tested in many diseases. Two studies have been done in ME/CFS, and a large and surprisingly comprehensive one is underway.
The Kenyon Study
They did well, though, in the first rather unorthodox ME/CFS Kenyon study, which had its participants take no less than 10 fecal transplants! It was also not placebo-controlled or methodologically rigorous, and consisted of a series of case reports.
Still, with the paper reporting that seven of the 21 treatment-resistant patients reportedly returned to full or near normal health, and six others received significant improvements in energy, the reports were encouraging indeed. One person who had been sick for decades reportedly returned to health.
It was good news, then, to hear that two more ME/CFS fecal transplant studies – a small one in Finland and a larger one in Norway – were underway.
The Finnish Study Fails
The Finnish study was small indeed – just 11 patients – and in contrast to the case series – which provided fecal matter transplants over ten days – the participants received one 30-gram treatment. Sometimes antibiotics are given to clear the bowel before treatment but not in this case.
The study was small but rigorously done. The participants had to meet the Canadian Consensus Criteria (CCC) for ME/CFS and the trial was placebo-controlled – meaning that some participants received the fecal matter while others received a placebo (a fecal matter transplant using their own feces). Plus, the fecal matter was delivered using a superior method of administration – a colonoscopy. Quality of life, visual analogue, and fatigue scales (MFI) were used to assess the effects of the treatment one month and six months later.
Unfortunately, there were no treatment effects; i.e. the patients receiving the fecal transplants were no better off after one or six months than those receiving the placebo.
Where We Are Now
We have one positive and one negative treatment result. One clear difference was that the Kenyon study used the Taymount Clinic’s ten-day protocol, which includes a colon irrigation, followed by ten fecal matter transplants.
Other fecal matter transplant studies have also used different protocols. The Chinese have been doing fecal transplants for a long time and appear to use more of them. One Chinese group, for instance, reported that it’s treated over 2,000 people with fecal transplants.
A large Chinese irritable bowel study, which gave an oral antibiotic (500mg vancomycin orally twice per day) for 3 consecutive days followed by transplants for 6 days, followed the participants for five years. The study reported 50-60% efficacy rates with fatigue and mental health scores improving by roughly 30-40%, which were largely maintained over the study. Periodic (apparently yearly) fecal transplants were generally needed to maintain efficacy.
- With the gut microflora (the gut-brain axis) able to affect the brain and cognition, and with dysregulated gut microflora implicated in chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) – finding a corrective gut flora treatment might be a big deal.
- So why not take up fecal matter transplants (FMT) – something Chinese medicine employed almost 2,000 years ago and which are effective against the very dangerous Clostridium difficile infections.
- Laura Pace, the co-founder of the Metrodora Institute, believes the difference in the flora between the bowel and the flora of the small intestine – where most of the digestion, etc. is – is too great to make them likely helpful. They are, however, being assessed in multiple diseases.
- Two studies have been done in ME/CFS. A case series from the Kenyon study which gave no less than 10 fecal transplants to its patients, reported that seven of the 21 treatment-resistant patients returned to full or near normal health, and six others received significant improvements in energy. One person who had been sick for decades reportedly returned to health.
- The recent placebo-controlled Finnish study included just 11 patients and the participants received one 30-gram treatment – but was much more methodologically rigorous. Unfortunately, there were no treatment effects; i.e. the patients receiving the fecal transplants were no better off after one or six months than those receiving the placebo.
- It’s possible that providing more fecal matter or providing it more times might have helped.
- The fecal transplant field is in flux. It’s not clear how much poop should be delivered, how it should best be delivered, or how many times it should be delivered to produce the best results.
- A 2020 review, “Current status of fecal microbiota transplantation for irritable bowel syndrome“, reported mixed results with four positive studies and three negative ones. The review concluded that larger doses (60g) were better and found that 70% of the people who did not respond to 30 grams – the dose used in the Finnish ME/CFS study – responded to 70 grams.
- The large and very comprehensive ME/CFS Norwegian Comeback study underway uses a higher dose (50-80 grams) and will periodically assess a comprehensive array of factors including the microbiome flora, leaky gut, heart rate variability, metabolomics and metagenomics analyses, and immune profiling (!).
- Containing 160 patients, the RESTORE ME placebo-controlled study – funded by Invest in ME – and begun in 2020, is even larger. It includes one transplant and will assess physical activity, and cognition and will analyze blood and fecal samples from the participants.
- According to its timeline, the last patient in the study has started the study, and the results are expected in a couple of years.
A more recent update of a 3-year IBS study, however, found that one FMT dose (30-60 grams), which was transplanted directly into the colon, was enough to allow most patients “maintain their response at 3 years”. The paper specifically noted the increase in two gut factors associated with ME/CFS – increased levels of the Faecalibacterium prausnitzii bacteria as well as butyric acid (butyrate).
While most Western studies appear to use one dose, t’s possible that the Finnish study, with its 30-gram dose, was underpowered. It’s also possible that multiple transplantations may be more effective. Doctors who employ them regularly may be finding that multiple transplants work better. That issue, however, has apparently not been well-explored in the scientific literature.
Field in Flux
With regard to ME/CFS and fecal transplants, we’re left with two widely differing results – something that’s not all that surprising given the flux the fecal transplant field is in. Questions regarding which donors are best, how much to give in each dose, the best method for transplanting the fecal matter, and the optimum number of doses pervade the field. With regard to ME/CFS, we don’t know if fecal transplants work best in people with ME/CFS and IBS or if they will also work in people with just ME/CFS, or if they work at all.
The large and quite comprehensive ME/CFS Norwegian Comeback study and the RESTORE ME studies should help. The Comeback study will using a higher dose (50-80 grams) delivered using an enema. Nowhere does the study explicitly state how many transplants are given – suggesting that it will include one dose.
The 80-person study which began in 2019 is placebo-controlled, uses validated questionnaires, follows the participants for 12 months, periodically assesses microbiome flora, leaky gut, and heart rate variability, does metabolomics and metagenomics analyses, and immune profiling (!).
This impressive study, which may be digging deeper into the physiological effects of fecal transplantation than any before it, began in 2019. Its last participant was slated to go through the study in March of this year, but the study is not expected to be complete until 2026.
Containing 160 patients, the RESTORE ME placebo-controlled study – funded by Invest in ME – is even larger. It includes one transplant and will assess physical activity, and cognition and will analyze blood and fecal samples from the participants. Since it has been underway since 2020, we should get the results sooner rather than later.
The Remission Biome project with its extensive use of antibiotics, keto diet and specialized probiotics is taking a different route. It’s now attempting to put 50 people with ME/CFS on its gut protocol.
Find out more about Remission Biome check out the blog below – and if you’d like to apply to be one of the 50 – go here.
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