Feces Transplantation: Its Future in Denmark

Highlights:

  • Feces transplantation effective than antibiotics in
    treating Clostridium difficile infection (CDI)
  • Feces transplantations, currently performed as part of
    research projects may become commercialized
  • New study recommends that Danish Tissue Banks should
    regulate feces transplantation in Denmark

Fecal
transplant, the process involving transplantation of fecal bacteria from a
healthy individual into a recipient with disease, has become increasingly
popular for treating recurrent Clostridium difficile infection (CDI).
Many recent studies, worldwide, have shown the effectiveness of feces
transplantation. A new study from Aarhus University has raised questions about
the future of feces transplantation in Denmark.


Clostridium
difficile (C. diff)
is a bacterium that causes mild to severe diarrhea and other intestinal symptoms. The
bacteria are found in the digestive system of about 1 in every 30 healthy
adults. In patients taking antibiotics, the balance of bacteria in the bowel
gets disrupted, which could lead to the multiplication of C.
difficile
bacteria, thereby making the patient ill. If not treated
immediately, patients may die from CDI.

The Study Design

The study led
by Christian Lodberg Hvas, a Consultant and a Clinical Associate Professor at
the Department of Clinical Medicine at Aarhus University, has been funded by
Danish Regions. The research team has compared the effect of feces
transplantation against two antibiotics that are currently being used to treat Clostridium
difficile
.

‘The future of feces transplantation as a treatment for Clostridium difficile, the life-threatening intestinal disease has an uncertain future in Denmark. However, the new study recommends that Danish Tissue Banks should regulate feces transplantation in Denmark.’
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120 patients
who were referred to Aarhus University Hospital with a Clostridium difficile
infection were included in the study. Of this, 64 patients were approved
for the randomized controlled trial. Among the 64, 24 were given feces
transplantation, another 24 were given the antibiotic fidaxomicin and the remaining 16 were
given a very reliable antibiotic, vancomycin.

Study Results

22 patients among the 24 who underwent feces
transplantation were cured after just single transplantation.
On the other
hand, only 10 patients of the 24 who took fidaxomicin were cured and just 3 out
the 16 study participants who took vancomycin were cured.

Moreover,
there was a recurrence of Clostridium infection in more than half of the
participants in the trial from the group who were given antibiotics after they
had completed a course of taking them. Therefore these patients were given a
‘rescue’ feces transplantation and ninety percent of them were cured by this.

Out of the
120 patients who were referred, 56 did not participate in the randomized trial,
because they were too ill or they could not cope with participating.
Subsequently, 49 patients received fecal transplantations as no other treatment
options were available and 39 of them were brought back to life.

Observations of the Study Team

Christian
Lodberg Hvas makes an observation, “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.”

Dr. Hvas and
team also concluded
that the study that challenges the assumption that patients
with a Clostridium infection may not be suitable to benefit from donor feces.
Dr. Hvas remarks,
“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.”

 

The team of
researchers recommends that fecal transplantation should be the first treatment
chosen in Denmark’s hospitals, in the future, as 9 out of every 10 patients are
cured by transplantation. Additionally, patients who are assessed ‘too ill’ to
receive a feces transplantation, should also consider having one.

Fecal Transplants in Denmark

In several
Danish hospitals, fecal transplants are currently performed as part of research
projects. In the autumn of 2018, Dr. Hvas and team received a grant of DKK 17
million from the Innovation Fund Denmark. This grant has been set aside for the
task of turning feces taken from healthy, registered and tested donors into
standard treatment. However, a treatment having the potential to cure 9 out of
10 patients will obviously interest companies that look to make a profit,
and could threaten the status of feces bank which is now a public project. This
is one of the many challenges in the way of adopting a fecal
transplant as a standard treatment.

Similar to
the scenario in Belgium and Netherlands, Dr. Hvas and his colleagues are now
following the regulations for safety and donations laid down in the Danish
Tissue Act, as there is no Danish legislation on feces transplantation
available yet. Building up and operation
of feces banks may likely continue in the future if authorities in Denmark
decide that feces donations should also be regulated in accordance with the
Danish Tissue Act.
On the contrary, the stool banks may be shut down if
authorities decide that the treatment should be considered as a form of
medication and hence must follow completely different legislation.

Dr. Hvas
explains, “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.”

Dr. Havs has
found it personally challenging to visualize how 50 grams of unprocessed feces,
blended with sterile saline and frozen to a temperature of minus 80 degrees
before being thoroughly tested and administered at a university hospital, could
be categorized as a form of medication. He and his colleagues are hoping that the Danish
Patient Safety Authority which regulates the Danish tissue banks would also
take the responsibility to regulate feces transplantation.

In
conclusion, Dr. Hvas mentioned, “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
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.”

References :

  1. Fecal Microbiota Transplantation is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection – (https://www.gastrojournal.org/article/S0016-5085(18)35434-9/pdf)

Source: Medindia