When waste isn’t wasted – A Detailed Review
There was a time when blood transfusions were met with fear and controversy but are now considered routine. What about a stool transfusion though?
Could the general population ever accept a Faecal Microbiota Transplant (FMT) as normal?
FMT is the process of transplanting microbes from the gut of a healthy donor to the gut of another, to replace good bacteria that has been killed or suppressed, usually by the use of antibiotics. The gut contains a microbiome of bacteria, viruses, fungi and single celled microorganisms that interact to aid digestion, regulate the immune system, protect against disease and manufacture vital vitamins. We are actually more microbe than human; only 43%1 of the cells in the body are human.
More potent than common probiotics
Due to the ageing population and increased prevalence of chronic diseases, there has been a movement from treatment to prevention and as the gut plays a major role in maintaining health, probiotics are increasingly popular. Whilst probiotics contain around 5 different strains of ‘good’ bacteria, FMT can contain an estimated 1000 species of microbes that have potential health benefits. The U.S. probiotics market is set to surpass $67bn by 20242and if the current positive growth surrounding FMT is maintained it can be assumed that it will be part of this substantial financial market.
FMT is successfully used to treat the potentially fatal infection caused by the bacterium, Clostridium difficile (C.diff) and studies have shown that an infusion of donor faeces is significantly more effective in treating recurrent C.diff than the antibiotic, vancomycin. Considering a study in 20153 showed that C.diff was linked to 29,000 deaths in one year and that the U.K. and Canada showed similar statistics, FMT could have a huge impact on healthcare, patient safety and avoidable deaths. Though historically a rare entity in Asia4, C.diff rates are rising and so a more effective treatment could prevent rates reaching the levels they have in the U.S. and Europe.
FMT is administered through of a solution of faecal matter from a donor, into the intestinal tract of a recipient via a nasoduodenal tube, a colonoscopy or an enema and oral capsules are available from faecal transplant clinics. Initial research has shown that capsules are as effective as delivery by colonoscopy for the treatment of C.diff5 which makes it more accessible. There are also preliminary indications to suggest that FMT may have therapeutic potential for other conditions including, IBS, autoimmune disorders, obesity, Parkinson’s, multiple sclerosis and depression. Due to the scarcity of randomised controlled trials, evidence is limited but so far, it is positive.
Clinic or DIY?
FMT is more established in the U.S. where there are hundreds of clinicians who offer the procedure compared to just one clinic and a handful of private doctors in the U.K. The first stool bank in Asia opened in Hong Kong in 2017 and in Singapore; the first EMT was carried out in 2014. Due to the growing online media hype around the benefits of FMT, there are also numerous websites (not for the faint hearted) that describe how you can carry out DIY transfusions.
There are risks of course, specifically around transferring pathogens that may be asymptomatic for the donor and transferring blood-borne illnesses. Lessons have been learnt since the tragic scandal of the contaminated blood and blood products of the 1970s and 1980s when more than 4,600 haemophiliacs contracted HIV or hepatitis C and the screening process has since advanced. Many clinicians and clinics will state extensive donor blood and stool screening processes however, as there is no definitive regulation, safety of FMT is of concern.
Although there are already established clinics, FMT in the U.S. does not have FDA approval yet, which is largely because no one can agree whether it is a drug or a human tissue. The FDA states FMT meets the description of a drug (which, interestingly, makes us all prolific pharmaceutical industries) and allows physicians to use their discretion to treat C.diff6. Health Canada allows FMT for C.diff but requires clinical trial applications to treat any other condition. The regulatory stance in Europe is just as unclear7. FMT is not covered by the European Human Tissue Directive and the European Commission specifies that individual member states are free to regulate FMT nationally.
A successful alternative to antibiotics
FMT marks a large change from how scientists have treated microbes, which has been mainly with antibiotics and vaccines. The side effect of eliminating infectious diseases this way though, is that according to the World Health Organisation (WHO) we are now facing one of the greatest threats to global health, antimicrobial resistance (AMR). A report by the European Commission8 commented AMR costs the EU €1.5bn each year and causes the deaths of 25,000 people annually.
There has also been a steep increase in autoimmune disease and allergies, and new diseases have been created by resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). The number of deaths will undoubtedly increase as the efficacy of the world’s antibiotics decreases. There is a global initiative to address AMR and this month the National Institute for Health and Care Excellence (NICE) and Public Health England (PHE) proposed guidelines9 around antibiotic prescribing including advising that honey and over the counter medicines should be the first line of treatment for most people with coughs, not antibiotics. Governments are taking AMR extremely seriously.
So what does the future hold for this treatment?
FMT is a crucial part of the emerging trend of creating next generation probiotics. This may mean diseases will not be primarily treated with antibiotics but by administering genetically modified microbes that would complement the health status of the host to fight infection as well as actively target certain diseases. Personalised medicine is fast developing as each person has their own unique bacteria mix and this diversity can have specific implications for disease in different populations e.g. European and Chinese citizens with type 2 diabetes have different gut microbiome compositions with the Chinese having more diverse species.10
It is known that microbiome manipulation can significantly influence health, as seen with C.diff, so once regulation has been resolved, refinement of FMT to a more targeted therapy will be the next step. The implications of FMT for patients and the health and life science industries are vast and with research showing that amongst its many benefits, it may also affect weight loss, already an industry worth over $2bn a year, this won’t be the last time you hear of FMT.
1 http://www.frontlinegenomics.com/news/21493/more-than-half-your-body-is-not-human/
2 https://www.gminsights.com/pressrelease/probiotics-market
3 https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html
4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3916678/
5 https://jamanetwork.com/journals/jama/fullarticle/2664458
6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4749851/
7 https://www.researchgate.net/publication/321343695_Faecal_microbiota_transplantation_A_regulatory_hurdle
8 https://ec.europa.eu/health/amr/antimicrobial-resistance_en
9 https://www.nhs.uk/news/heart-and-lungs/honey-not-antibiotics-recommended-coughs/
10 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785832/
Caroline White is a specialist Healthcare Risk Control Director at CNA Hardy and works closely with our healthcare customers to integrate risk awareness and prevention into their corporate strategy and decision making.
Email – [email protected]