The Department of Health has launched the Microbiota Bank of Catalonia, a pioneering initiative in the public sphere that positions the Catalan health system as a benchmark for the State and Europe in the therapeutic use of faecal microbiota. This bank will extend access to innovative, effective, and safe treatment for patients with recurrent Clostridioides difficile infections to all centres of the comprehensive public health system in Catalonia (SISCAT).
This project was born as a public, centralised and coordinated model, with the involvement of the Catalan Transplant Organisation (OCATT), the Blood and Tissue Bank (BST), the Bellvitge University Hospital and the Hospital Clínic de Barcelona. Since 2014 and until now, these two reference centres have jointly treated 171 patients with C. difficile infections by fecal microbiota transplantation (FMT). With the opening of the bank throughout the public system, it is estimated that up to 200 patients each year will be able to benefit from this treatment.
A pioneer in Spain and one of the first in Europe, the Microbiota Bank of Catalonia was presented today at a press conference with two different objectives: to extend this therapeutic modality to the entire Catalan public health system, making it accessible to all citizens in an equitable way, and to promote research into the application of this new treatment to other diseases.
An innovative treatment for a serious and recurrent clinical problem
Currently, fecal microbiota transplantation is only used to treat Clostridioides difficile infection. This infection affects almost exclusively patients with altered microbiota (what is known, in medical terms, as dysbiosis), in most cases, due to the use of antibiotics and in a hospital environment. In Catalonia, there are about 2,500 episodes each year.
Infection by this bacterium is a serious intestinal condition that can cause persistent diarrhea, dehydration and even put the patient’s life at risk. In most cases, it is a medical problem that arises from a paradox: the use of antibiotics predisposes to the alteration of the microbiota that ends up causing C. difficile infection, which is treated with antibiotics. Antibiotic treatment helps to resolve the infection, but in 1 in 4 or 5 patients, and depending on their individual characteristics, what it causes, of course, is a maintenance of the original dysbiosis. In other words, because of antibiotics, the microbiota is not able to restore itself and return to a normal state, perpetuating its alteration over time.
It is then that a vicious circle is entered: the patient continues to have an altered microbiota, contracts a C. difficile infection again, is treated with antibiotics, dysbiosis is maintained, relapses, is treated again… And relapse is becoming more frequent: if in the first infection the risk of relapse is 25%, in the second it is 40%. Thus, the starting signal is given to a repetitive and continuous pattern of infection-resolution-relapse that has a direct impact on quality of life. “I expected to have a complicated life from here on out, with very poor quality and linked to recurrent infections, needing antibiotics for the rest of my life,” explains Santiago Marco, a patient who has given his testimony.
Breaking the vicious circle with microbiota transplantation
Fecal microbiota transplantation breaks this vicious cycle, offering a solution focused on restoring the balance of the gut microbiome and eliminating the activity of the bacteria. The basic idea is simple: if the altered microbiota predisposes to infections, it must be reinforced with healthy microbiota.
And the procedure to do it is also simple. In the words of Dr. Jordi Guardiola, head of the Digestive System Service at Bellvitge University Hospital and principal investigator of the Pathology of the Digestive Tract research group at IDIBELL, “It basically consists of removing from the faces everything that makes it faeces, and making a concentrate of beneficial healthy microorganisms to pass it from a healthy donor to a sick patient with an altered microbiota.“. To this end, the main routes of administration have been oral, with fecal microbiota capsules (67.8%), followed by colonoscopy (32.1%).
And the success is resounding: if with standard treatment the cure is 30%, with microbiota transplantation practically everyone is cured. 85% of patients with recurrent colitis due to Clostridioides difficile do so in the first transplant, and a small percentage need a second transplant that raises the success rate to close to 100%.
The requirements to be a donor
Being a faecal microbiota donor is not easy, it is estimated that only 5-7% of volunteers end up being one. “The degree of altruism required to be a stool donor is greater than that of being a blood donor, because a series of parameters must be strictly complied with and it implies a very high commitment from the donor when it comes to respecting certain rules,” explains Begoña González, head of the Fecal Microbiota Donation and Transplantation Program at the Hospital Clínic de Barcelona.
To be a microbiota, it is essential to avoid situations that can alter the microbiota. Totally healthy microbiota is needed, so donors must not only be between 18 and 60 years old, but must also have healthy lifestyle habits, not suffer from any disease, have not taken antibiotics in the last 3 months and have not travelled outside the European Union in the last 6 months. Any of these situations is likely to alter the microbiota and make the donor ineligible.
An open door to future clinical applications
The Microbiota Bank of Catalonia has been created with a focus clearly aimed at a very specific clinical problem, but with an open and scalable model. Although it is currently only aimed at patients with C. difficile infections, from the beginning it opens the door to being able to expand its use to other diseases and patients in the future, subject to the existence of solid scientific evidence and authorization by the competent regulatory authorities.
To collect this scientific evidence, a lot of research and effort is needed, of the same kind that led to the idea and proposal of microbiota transplantation as a treatment for recurrent C. difficile infections. But the reward and social impact on the health of the population is enormous. As Santiago Marco, who managed to break the vicious circle of recurrent infections thanks to a microbiota transplant, says, “Finding clinicians in your country who are doing research to bring solutions to patients like me changed my life“.
The Bellvitge Biomedical Research Institute (IDIBELL) is a research center established in 2004 specialized in cancer, neuroscience, translational medicine, and regenerative medicine. It counts on a team of more than 1.500 professionals who, from 73 research groups, publish more than 1.400 scientific articles per year. IDIBELL is participated by the Bellvitge University Hospital and the Viladecans Hospital of the Catalan Institute of Health, the Catalan Institute of Oncology, the University of Barcelona, and the City Council of L’Hospitalet de Llobregat.
IDIBELL is a member of the Campus of International Excellence of the University of Barcelona HUBc and is part of the CERCA institution of the Generalitat de Catalunya. In 2009 it became one of the first five Spanish research centers accredited as a health research institute by the Carlos III Health Institute. In addition, it is part of the “HR Excellence in Research” program of the European Union and is a member of EATRIS and REGIC. Since 2018, IDIBELL has been an Accredited Center of the AECC Scientific Foundation (FCAECC).