Fecal Transplantation Facing an Uncertain Future

Nine out of 10 patients are cured by a fecal 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 bring 'too ill' to receive a fecal 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 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.

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 fecal transplantation, while the remainder were given antibiotics.

The study showed a large and significant difference between the fecal 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 fecal 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 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' fecal transplantation -- and 90 percent of them were cured by this.

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 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 fecal 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."

Faeces transplantations are currently performed at several Danish hospitals as part of research projects, and in Autumn 2018, 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 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 Belgium and Netherlands, because there is not yet any Danish legislation on fecal 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 U.S. 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 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 fecal 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 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 Hvas.

Source: Aarhus University