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Faeces transplantation: effective treatment facing an uncertain future

In the right intestines, faeces can save lives. This is shown by a new study of faeces transplantation and the life-threatening intestinal disease Clostridium difficile. Medical doctors and researchers from Aarhus, Denmark, are presently building up a faeces bank, but both the treatment and its non-targeted research could be about to come under pressure.

The study showed a large and significant difference between the faeces transplantation and the antibiotics, which are today considered to be state of the art. Photo: Mette Mejlby Hansen, AU/AUH.
Our study shows that the more poorly the patient is, the stronger the arguments for a faeces transplantation actually are, says Christian Lodberg Hvas. Photo: John Christensen, AUH.

Nine out of ten patients are cured by a faeces transplantation, in which faeces from a donor is inserted into the patient’s intestines via an endoscope or probe. For this reason the transplantation should in future be the first treatment chosen in Denmark’s hospitals. And this should also be the case for patients who are currently assessed as bring ‘too ill’ to receive a faeces transplantation. 

This is the conclusion reached by Christian Lodberg Hvas on the basis of a new study. He is a consultant at Aarhus University Hospital and a clinical associate professor at the Department of Clinical Medicine at Aarhus University. A conclusion which challenges the general assumption that patients with a Clostridium infection can be too poorly to benefit from donor faeces. 

“We now know this is wrong. Our study shows that the more poorly the patient is, the stronger the arguments for a faeces transplantation actually are,” says Christian Lodberg Hvas. 

The results of the study – which is financed by Danish Regions – have recently been published in the international journal Gastroenterology. In the study, the researchers compared the effect of faeces transplantation against two types of antibiotics currently being used to treat Clostridium difficile.

Tested in a randomised controlled trial 

The study included 120 patients who had been referred to Aarhus University Hospital with a Clostridium difficile infection. Sixty-four of them were approved for a randomised controlled trial, and of these 24 received a faeces transplantation, while the remainder were given antibiotics.

The study showed a large and significant difference between the faeces transplantation and the antibiotics, which are today considered to be state of the art: A total of 22 out of the 24 patients were cured after just a single faeces transplantation, while only ten out of 24 patients were cured using the antibiotic fidaxomicin. Results were even worse for the 16 patients who tested the most well-proven type of antibiotic which is called vancomycin. In this case, only three out of 16 trail participants were cured. Additionally, more than half of the participants in the trial from the group who were given antibiotics suffered from a Clostridium infection again after completing the course of antibiotics. This group therefore received what is known as a ‘rescue’ faeces transplantation – and ninety per cent of them were cured by this. 

Dramatic effect – also on the most poorly patients

Out of the 120 referred patients, 56 were not included in the randomised trial, either because they were too ill or because they could not cope with participating. So a total of 49 patients subsequently received a faeces transplantation because there were no other options left, and of these 39 were literally brought back to life. As Christian Lodberg Hvas notes: "If the Clostridium difficile infection isn’t remedied in the most poorly patients, they will die from it. So we’re often having a conversation about life or death when we make an agreement with the patient about the treatment. The effect of a faeces transplantation is very dramatic, as after only a few days it makes it possible for very poorly patients to get up from their sick bed so they can be sent home to lead a normal life again – though we naturally still keep a close eye on them." 

Tissue or medication?

Faeces transplantations are currently performed at several Danish hospitals as part of research projects, and in Autumn 2018, Christian Lodberg Hvas and his research group received a grant of DKK 17 million from the Innovation Fund Denmark. The grant is earmarked for the task of turning faeces taken from healthy, registered and tested donors into standard treatment in Denmark. However, there are challenges on the horizon. One is that a treatment which cures nine out of ten patients will naturally be of interest to companies that exist to make money, and that this could threaten the faeces bank’s status as a public project. 

At present, Christian Lodberg Hvas and his colleagues follow the regulations for safety and donations laid down in the Danish Tissue Act, just as the case in e.g. Belgium and Netherlands, because there is not yet any Danish legislation on faeces transplantation. If the authorities in Denmark decide that faeces donations should in future also be regulated in accordance with the Danish Tissue Act, then the work of building up the faeces bank will continue as before. On the other hand, if the authorities instead decide that the treatment should be treated as a form of medication and must thus follow a completely different legislation, then the faeces bank as a public project will shut down. 

"To put it simply: As a hospital, we cannot produce medication, so if faeces transplantation is determined to be a form of medication, we cannot continue. This will mean that the treatment will be taken over by pharmaceutical companies, a process that’s underway in the USA and elsewhere, because it’s an area with large commercial interests at stake," says Christian Lodberg Hvas. 

Set research free

Personally, he has difficulty seeing how fifty grams of unprocessed faeces that is blended with sterile saline and frozen to a temperature of minus 80 degrees before being thoroughly tested and administered at a university hospital, can be classified as a form of medication. And he and his colleagues now hope that the Danish Patient Safety Authority which regulates the Danish tissue banks will also be the ones to regulate faeces transplantation.

"For us, it's also a question of ensuring that research continues to be free. As a university or university hospital, we don’t have to make money from patents and commercialisation – what we must do is ensure effective treatment in hospitals, and we can only offer this if the authorities permit it. So we’re really anxious to hear what decision the authorities make," says Christian Lodberg Hvas.

Clostridium and the faeces bank – more information

  • The life-threatening disease Clostridium difficile is a kind of “weed” bacterium that can grow if there are no other bacteria to stop it. Clostridium grows e.g. when someone uses antibiotics and is already ill or otherwise in a weakened state.
  • So far, seventeen healthy faeces donors have been added to the new faeces bank – all of them were recruited through the Danish blood bank where they already donate blood. Stool samples must be submitted within two hours in special sterile containers.
  • As a faeces donor, you must be of normal weight and free of medication, as there are many indications that overweight and allergies can be transferred via intestinal bacteria.

The research results – more information 

  • The study was a randomised clinical trial carried out between April 2016 - June 2018 at Aarhus University Hospital. It was quality assured by the Good Clinical Practice Unit.
  • The study was financed by the Danish Regions' Medicines Pool under the Danish Regions organisation and cost a total of DKK 2.5 million to complete. A total of 120 patients were assessed in the study. Of these, 95 received a faeces transplantation.
  • The partners involved in the study were: the Department of Hepatology and Gastroenterology and the Blood Bank, Aarhus University Hospital; the Department of Business and Management, Aalborg University; and the National Food Institute, Technical University of Denmark. All are involved in the Centre for Faeces Transplantation (CEFTA).
  • The scientific article has been published in full and can be found on the Gastroenterology website (link).


Consultant, Clinical Associate Professor, Christian Lodberg Hvas
Department of Hepatology and Gastroenterology, Aarhus University Hospital.
Department of Clinical Medicine, Aarhus University
Tel.:(+45) 2835 1839
Email christian.hvas@auh.rm.dk.