Nine out of ten patients are cured by a feces transplantation, in which feces 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 being "too ill" to receive a feces 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. This conclusion challenges the general assumption that patients with a Clostridium difficile infection can be too ill to benefit from donor feces.

"We now know this is wrong. Our study shows that the more poorly the patient is, the stronger the arguments for a feces transplantation actually are," says 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 feces transplantation against two types of antibiotics currently being used to treat C. difficile.

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

The study showed a large and significant difference between the feces 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 feces transplantation, while only 10 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 3 out of 16 trial participants were cured.

Additionally, more than half of the participants in the trial from the group who were given antibiotics suffered from a C. difficile infection again after completing the course of antibiotics. This group, therefore, received what is known as a 'rescue' feces transplantation—and 90% of them were cured by this.

Out of the 120 referred patients, 56 were not included in the randomized trial, either because they were too ill or because they could not cope with participating. So a total of 49 patients subsequently received a feces transplantation because there were no other options left, and, of these, 39 were literally brought back to life.

As Hvas notes, "If the C. 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 feces 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."

Feces 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 feces 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 9 out of 10 patients will naturally be of interest to companies that exist to make money, and that this could threaten the feces bank's status as a public project.

At present, Hvas and his colleagues follow the regulations for safety and donations laid down in the Danish Tissue Act, just as in Belgium and the Netherlands, because there is not yet any Danish legislation on feces transplantation. If the authorities in Denmark decide that feces donations should in future also be regulated in accordance with the Danish Tissue Act, then the work of building up the feces 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 feces bank as a public project will shut down.

"To put it simply: As a hospital, we cannot produce medication, so if feces 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 Hvas.

Personally, he has difficulty seeing how 50 grams of unprocessed feces that is blended with sterile saline and frozen to a temperature of -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 feces transplantation.

"For us, it's also a question of ensuring that research continues to be free. Unlike the university or university hospital, we don't have to make money from patents and commercialization—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 Hvas.