Fecal Transplantation

Fecal microbiota transplantation (FMT)

At the Institue of Predictive and Personalized medicine (IPPM) we offer world-class Faecal Microbiota Transplantation (FMT) treatment to our patients to help them restore their gut flora and digestive health.

Currently, we are the only private clinic in Central Europe providing FMT treatment and one of handful of clinics in the whole world offering FMT treatment using specially prepared fecal implants from a donor bank, rather than unprocessed stool.

What is faecal microbiota transplantation (FMT)?

The gut flora, also known as the gut microbiota, is a complex and diverse ecosystem that plays a crucial role in regulating the functioning of the whole human body.

We now know that a balanced and diverse intestinal microbiota is one of the main prerequisites for a healthy life. On the contrary, loss of this balance has been shown to play a role in a large number of not only gastrointestinal but also other diseases.

Fecal microbiota transplantation (FMT), also known as Gut Flora Transplant (GFT), is the process of implanting intestinal microbiota from a healthy donor into the gastrointestinal tract of the recipient. This process restores the recipient’s intestinal flora and increases bacterial diversity, helping to achieve an optimal function of the intestinal system. Healthy intestinal microbiota is extracted from the stool of a donor using a special filtration method. The result is a liquid suspension containing complete, balanced microbiota without any residues and digestion by-products.

Clinical research on Fecal transplantation (FMT) has dramatically increased in the last few years and is still ongoing. The results of existing clinical studies show that FMT treatment can be beneficial for a wide range of acute and chronic diseases and new findings are being published constantly.

 

Existing research on gut microbiota and clinical uses of FMT

Infections caused by Clostridium difficile or other pathogens

Clostridium difficile infections are caused by the overgrowth of this harmful bacteria in the digestive tract. Symptoms of the disease include severe diarrhea (sometimes containing blood), nausea, abdominal pain, vomiting and fever.

Intestinal infections caused by C. Diff. bacteria are often very resistant to antibiotics, and in some patients the infection can last for months despite antibiotic treatment. In such cases, fecal transplantation treatment is recommended. Clinical studies show that fecal transplantation can cure Clostridium difficile infections in more than 90% of cases.1 As a result, FMT is now indicated as the treatment of choice in patients with antibiotic-resistant recurring C. diff. infections.

FMT has also been successfully used to treat infections caused by other pathogenic bacteria. Singha et al. (2018) for example used FMT to treat gut infections caused by Enterobacteriaceae bacteria producing beta-lactamase (ESBL) – an enzyme that that blocks the effects of antibiotics. This makes these bacteria extremely resistant to antibiotic therapy. The results showed that after 2 FMT implants 40% of patients were completely cured of the infection.2

Inflammatory bowel disease (IBD) - Ulcerative colitis and Crohn's disease

IBD is a chronic, auto-immune inflammatory disease that affects the intestinal tract. Depending on where the inflammation is localized in the intestinal tract, the disease is split into ulcerative colitis or Crohn's disease.

Although the exact cause of this disease is not yet known, some studies have revealed a link between IBD and the gut flora. Specifically, they have shown that the diversity of the gut flora is generally reduced in patients with IBD. Conversely, an increase in the diversity of the intestinal microbiota in patients with IBD is associated with the onset of remission and a reduction in the severity of IBD symptoms.3

Since fecal transplantation is one of the most effective ways to increase the diversity of intestinal flora, its therapeutic use in the treatment of IBD has already been investigated by several studies and the research is ongoing.

To date, two large double-blind clinical trials investigated the use of FMT in dozens of patients with ulcerative colitis. The results of both trials have shown that the efficacy of this therapy in inducing and sustaining remission was many times higher in FMT patients than in the control group. 4,5

The same conclusion was reached by experts at Helen DeVos Children's Hospital in Michigan, who found that faecal transplants administered in the form of an enema were very effective and well tolerated in children, and helped to reduce the symptoms of ulcerative colitis.6

In Crohn's disease, a large, randomized clinical trial is still pending. However, several smaller studies have shown that FMT has the potential to help with this type of disease. For example, the results of a 2015 study (Zhang et.al) showed that 23 out of 30 (76.70%) patients with Crohn's disease achieved remission or reduction in symptoms after FMT treatment.7

Irritable Bowel Syndrome (IBS) and Chronic Constipation

Irritable bowel syndrome is a disease that affects 10-15% of the population.8 It’s the most widespread gastrointestinal disease characterized by unpleasant symptoms such as: bloating, abdominal pain, diarrhoea or constipation and flatulence. IBS is divided into different sub-types depending on whether the patient’s primary symptom is diarrhoea (IBS-D) or constipation (IBS-C), and some patients are known to move between the subtypes over time.

As with other gastrointestinal diseases (e.g. IBD), more and more research is starting to highlight the connection between this disease and the gut flora. IBS patients, for example, generally have lower gut microbiota diversity as well as reduced amounts of beneficial strains of bacteria such as Lactobacillus and Bifidobacteria.8

In view of these findings and due to the ability of FMT to restore the gut flora back to its optimal state, studies have examined the potential use of FMT as a novel form of IBS treatment.

A randomized clinical study from 2018 examined the efficacy of FMT in several dozen patients with IBS. The results were very positive - after 3 months of FMT treatment, 35 out of 55 patients reported a significant reduction in IBS related symptoms. This corresponds to a 65% success rate.9

A very high success rate has also been demonstrated in the treatment of patients with long-term constipation. In a different study, up to 90% of patients confirmed an immediate improvement in clinical symptoms after FMT therapy and the improvements persisted for several months after therapy in 60% of patients.10

Chronic fatigue syndrome (CFS)

Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a disease characterized by symptoms such as fatigue, lethargy, stress, sadness, loss of motivation and sleep disturbances. The exact cause of this disease has not yet been determined but it’s very likely that CFS is a multifactorial disease, meaning that its caused by multiple underlying factors.

We now have evidence that people suffering from chronic fatigue syndrome often show various changes in the composition of intestinal microbiota (dysbiosis), which may be one of the factors behind the development of CFS/ME.11 Patients with CFS/ME very often also suffer from irritable bowel syndrome (IBS), which is another good indication that the disease is strongly associated with the intestinal system.12

A 2012 study (Borody et al.) monitored the efficacy of FMT in 60 patients with chronic fatigue syndrome, with most patients also suffering from IBS. After receiving FMT treatment, improvements in CFS-related symptoms were observed in 70% of patients. Interestingly, 12 of these patients were contacted 15-20 years after the study and 7 of them reported that their CFS/ME symptoms never returned. The remaining 5 reported that although the disease did eventually return, they were symptom-free for several years after FMT treatment.13 Randomized, double-blind clinical trials investigating the efficacy of FMT in chronic fatigue syndrome are currently under way, and their results should be available in the coming years.

Non-gastrointestinal autoimmune conditions

Gastrointestinal micro-organisms provide their host with significant health benefits, one particular benefit being the regulation of the immune system (immune homeostasis). In addition, it has recently been shown that negative changes in the balance of intestinal microbial communities can cause immune system dysregulation, contributing to the development of autoimmune disorders.14 Currently, researchers are focusing on revealing ways in which intestinal microbiota interacts with the immune system and how these processes relate to autoimmune diseases.

We now know of several autoimmune diseases (other than IBD) in which the role of the gut flora has been confirmed. Examples include:

• Thyroiditis (Hashimoto's syndrome)15

• Rheumatoid arthritis16

• Type 1 diabetes17

• Psoriasis18

• Systemic lupus erythematosus19

 

However, more research, specifically on the use of FMT in these conditions is needed to be able to determine whether FMT can actually help in these cases. Until then, the use of FMT in these conditions is strictly experimental, with no guaranteed outcome.

Neuorological conditions

The gastrointestinal system and the brain constantly communicate through the peripheral nervous system, hormones and the immune system. Some bacteria found in the gut even produce neurotransmitters, just like our neurons. It has also been recently discovered, that the gut is able to communicate directly with the brain through the vagus nerve, which links the gut to the brain stem.20

Therefore, it’s no surprise that even in neurological diseases, associations between changes in the intestinal flora and symptoms of the disease have been found. For example, patients with Parkinson's disease show stereotypical quantitative and qualitative changes in their intestinal microbial composition compared to healthy people.21

The question remains what role these changes play in the course of the disease and whether they are the cause or only the consequence. In assessing the success of FMT therapy in neurological diseases, we are working with a very limited amount of existing clinical data. At the moment only case studies are available, with clinical trials still under preparation. For example, a clinical trial was announced in January 2019, which will examine the efficacy of FMT therapy in patients with Parkinson's disease.22

Worth mentioning is a case study focusing on three wheelchair-bound patients with multiple sclerosis in advanced stage of the disease. FMT was administered to all three patients mainly in the hopes of helping to reduce the chronic constipation that they were all suffering from. The results however were very surprising. FMT didn’t just eliminate their constipation, but also dramatically improved the neurological condition of all three patients. Two of the three patients were able to stand up and walk again after FMT.23

Although the results of the above-mentioned case study are very positive, it should be emphasized that this is not a clinical study and the number of participants was very small. Large scale clinical research is needed to confirm the findings before drawing any conclusions. Currently, the use of FMT therapy in neurological diseases falls under ​​experimental supportive therapy. FMT is absolutely not a substitute for prescribed treatment, nor is it a cure.

Autism spectrum disorders

Autism Spectrum Disorder (ASD) is a group of brain development disorders defined by stereotypical behavior with communication and social interaction deficiencies. In 2012, the incidence of this disorder was estimated at 14.6 per 1000 children aged 4.24

To date, the exact causes of ASD haven’t been fully understood and the available treatment methods are very limited. Previous studies focused in particular on investigating the role of genetic causes, immune system dysregulation, inflammation, the impact of toxic substances and intestinal microbiota.

Clinical findings indicate that gastrointestinal symptoms such as abdominal pain, flatulence, diarrhoea or constipation occur in patients with ASD much more frequently than in the rest of the population. Additionally, it was found that children with ASD who also suffer from gastrointestinal problems score worse when it comes to typical ASD symptoms such as mood swings, hyperactivity, and socialization/communication deficiencies.25,26 Therefore, the treatment of GI symptoms in children with ASD is receiving ever more attention.

Several clinical studies have demonstrated that the composition of intestinal flora in autistic patients differs significantly compared to healthy populations. For example it been found that patients with ASD suffering from constipation have an increased presence of particular strains of bacteria such as Escherichia / Shigella and Clostridium in the gut. On the contrary, other bacterial strains are often under-represented.27

Currently, research is focusing on the use of FMT in the treatment of ASD based on the assumption that FMT can normalize intestinal microbiota in these patients and reduce GI symptoms.28

A recent clinical trial conducted in 2017 confirmed this hypothesis in practice. FMT therapy was administered to 18 children with ASD aged 7 to 16 years. All children also suffered from gastrointestinal symptoms. The results of the study showed that after treatment, gastrointestinal symptoms such as constipation, diarrhoea and abdominal pain were reduced on average by 80%. More surprising, however, was the finding that there was a significant reduction in ASD-related symptoms in children after FMT, such as moodiness, hyperactivity, lethargy, stereotypical behaviour, and speech/communication problems. As a result, the mean development age (measured on the VABS-II clinical scale) in these children increased by 1.4 years after FMT and these positive changes persisted even 2 months after treatment.28

Despite the very positive results of this pilot study, it is worth mentioning that the use of FMT therapy in children with ASD is a completely new concept and falls under experimental treatment. Other clinical trials are necessary to confirm the efficacy of FMT in ASD patients, particularly in children without digestive problems.

Liver and Bile duct (cholangitis) diseases

Fecal transplantation has recently been experimentally used to treat bile duct inflammation (cholangitis) with positive results. A small 2017 pilot study examined the efficacy of FMT in 6 patients with chronic cholangitis. Three out of 6 patients experienced a 50% reduction in blood ALP levels after administration, indicating an improvement in liver function. This was accompanied by changes in the composition of patients' gut flora and increased microbiome diversity.29

The use of FMT for other liver diseases is currently the subject of experimental investigation. A different 2017 study describes the experimental use of FMT in the treatment of patients with cirrhosis of the liver and hepatic encephalopathy. The outcome was "reduced hospitalizations, improved cognition, and dysbiosis in [patients with] cirrhosis with recurrent HE".30 Another clinical trial investigating the use of FMT in cirrhosis of the liver is currently underway.31

Obesity, diabetes and metabolic syndrome

The development and radical increase in obesity and metabolic syndrome are associated with genetic predispositions and environmental factors. A large number of clinical studies have confirmed that intestinal microbiota plays an important role in the development of obesity and associated symptoms such as metabolic syndrome and diabetes. It has also been found that lean and obese individuals show differences in the composition of their gut flora.32,33

Therefore, FMT is being explored as a novel form of treatment for these diseases. A study from 2017 examined the efficacy of FMT in patients with metabolic syndrome. The results showed that following the transplantation of microbiota from healthy, lean donors, approximately half of the patients experienced an improvement in their condition.34

Currently, a clinical trial examining the efficacy of FMT therapy in obesity is underway. Results are expected at the end of 2019.35

Allergies and Intolerances

According to a report by Mazzocchi et. al (2017), bacteria which naturally inhabit our digestive tract play a role in preventing allergies and at the same time may help in their treatment and elimination. An important role of intestinal bacteria is their involvement in the activation of the mucosal immune system to prevent the passage of allergens directly into the bloodstream.36 The use of FMT in treatment of allergies is currently the subject of research. For example, a clinical trial is currently underway in the US to test the efficacy of FMT in treating people with severe peanut allergy.37

Other conditions

Please note that the above is not a complete list of conditions for which FMT has been or could be used for. New findings about FMT and the role of microbiota in various diseases are being published constantly. We strongly recommend that all of our patients do their own research on FMT and their condition to decide whether the treatment is right for them. Additionally, if you're not sure whether FMT could be useful in your specific case, please feel free to contact us and we will be happy to give you our advice.

 

How does it work?

Thanks to our partnership with the Taymount Clinic, we can provide the best microbiota implants that currently exist.

The process starts with the careful selection of a healthy donor. All donors need to undergo thorough and regular medical examinations that include testing for a wide variety of conditions, including infectious diseases such as HIV and hepatitis. During this process the medical history and predispositions of the donors are also assessed and donors with an increased risk of developing certain conditions aren’t eligible to donate stool.

All donors need to follow lifestyle and diet recommendations, which ensures that their intestinal ecosystem is at an optimal, balanced level. To make sure that’s really the case, all donors also undergo microbiome testing, which analyses parameters such as the composition and diversity of their intestinal flora. Finally, the stool is checked to rule out the presence of parasites and pathogens. Only stool that meets all these strict parameters and contains a balanced and varied intestinal flora is used for further processing.

Unlike some other FMT providers, we do not use whole, unprocessed stool. Instead, donated stool is filtered under special anaerobic conditions to remove all waste material such as digested food residues, mucus, dead cells, hormones etc. At the end of this process we’re left with liquid implants that contain only gut microbiota, which significantly reduces the potential health risks and side effects of FMT.

The next step is to deep freeze the implants under laboratory conditions for later use. Transplants are stored and tracked to ensure continued safety and quality. All implants are quarantined for at least 3 months before being administered since some diseases, such as HIV, have several months long incubation time before they show up in tests. Therefore, only after a donor has been tested and then re-tested again after 3 months will the implants made from his/her stool be released for administration. The risk of transmitting an infection through the implants is therefore reduced practically to zero.

The implants are administered through a small rectal catheter (enema). For proper distribution of the applied material, special massage, positioning and short rest on the bed are used. The procedure is painless and the administration itself takes only a few minutes, with the whole procedure lasting about an hour per day. The whole treatment takes 1-2 weeks to complete, depending on the number of implants being administered.

 

Post-FMT care

Although FMT is a major step towards a regaining a healthy digestive system, we only see it as one piece of the puzzle. At IPPM we focus on a providing a comprehensive treatment protocol that aims to optimize intestinal microbiota, to revitalize the intestinal mucosa as well as to offer lifestyle recommendations. During your stay at the clinic, we will give you advice on how to take good care of your new gut microbiota even after returning home to ensure that you’re able to maintain the benefits of FMT treatment long-term.

 

How to proceed if you're interested? 

If you're interested in having FMT treatment at our clinic please contact us by filling out the form in the contact section. Please make sure to include your name, correct email address and phone number and a brief description of your medical problems. We will then contact you via the email address that you provided and send you more information about the treatment process. We also offer free initial consultation via Skype or over the phone for all prospective FMT patients. 

 

 

Bibliography

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