Older people with Clostridioides difficile infection (CDI) have fewer hospitalisations and survive more often following a faecal microbiota transplantation (FMT) administered by a home care team. This improves their quality of life and reduces the cost of healthcare per person considerably.
Kirsten is 73 years old and lies exhausted in bed with life-threatening diarrhoea caused by CDI. She is so weak that she cannot be hospitalised. A geriatric home care team visits and gives her 25 capsules of FMT from a healthy donor – and the next day the diarrhoea is gone and her appetite has returned.
A new health economics study from Aarhus University Hospital and Aarhus University in Denmark shows that at-home treatment by a geriatric home care team is more effective and more cost-effective than standard care. Combining these two measures more often eliminates the infection, reduces hospitalisation by an average of six days, reduces the number of acute rehospitalisations by two thirds and saves society DKK 19,000 in healthcare costs per person treated.
“It is difficult to be dissatisfied with this,” says Christian Lodberg Hvas, Consultant Gastroenterologist, Aarhus University Hospital and Clinical Professor, Aarhus University, Denmark.
“The geriatric home care team is trained to provide FMT, which we already know is the most effective treatment, and this makes it easier for people to receive it. FMT makes people feel better immediately, get less sick, have fewer rehospitalisations and fewer relapses,” he explains.
Such good results are unusual in a healthcare system in which new treatments are often effective but also much more expensive than standard care. His great hope is that the new results resonate in the healthcare system and may lead to the introduction of new treatment methods.
The ambition is to get those in authority to act on the results by making home care teams with expertise in FMT the first choice. The first step is a discussion with hospital management. The next step is to involve politicians, who can facilitate implementing FMT regionally and perhaps nationally.
Teaming up with a health economist
Although Christian Lodberg Hvas knows a lot, he admits that he does not know much about health economics. To determine whether outsourcing FMT to emergency responders is cost-effective, he teamed up with the Nordic Institute for Health Economics, a private company founded by Lars Ehlers, a former professor of health economics. The company sells health economic analyses to research communities at universities and elsewhere.
As a basis for the health economic analysis, the researchers used data from a clinical study published by Christian Lodberg Hvas and colleagues in The Lancet Healthy Longevity.
The study included 217 participants older than 70 years with confirmed C. difficile infection, randomly assigned to two equal groups.
One group was assigned to a geriatric home care team that could assess and treat older people at home, including administering FMT if appropriate. The other group was treated by existing healthcare professionals, typically in hospital, but some could also be treated at home. However, at-home FMT was not available to this group. Participants had to attend hospital as outpatients to receive FMT.
The results revealed that fewer deaths among those who died during the follow-up period were directly caused by the infection in the at-home FMT group (44%) versus the standard group (82%). The overall mortality rate – regardless of cause – was about the same for both groups, since the participants were generally very ill and frail. The difference in access to FMT may have contributed to more people in the home group receiving the most effective treatment quickly.
Really amazing
However, many other trials have established the fact that FMT reduces mortality. This includes a study in the Netherlands in which 90% of the people receiving FMT recovered. Although that study only included 16 people, the results were so convincing that the study was published in the New England Journal of Medicine, the world’s highest-ranking medical journal.
To emphasise the impact of the results, Christian Lodberg Hvas explains the concept of the number needed to treat, which indicates how many people need to be treated with healthy faeces from a healthy donor to save one person. For FMT against C. difficile, this number is 1.5 based on a meta-analysis.
“This means that two thirds of those treated are saved, which is really amazing,” adds Christian Lodberg Hvas.
In 2018, 28% of the people older than 70 years died within three months of their first CDI. Introducing FMT has halved the mortality rate to about 15%. In addition, only 10% of the people treated at home relapse – versus up to two thirds of those who complete a course of antibiotics.
“Even if the bacterial infection subsides, there are enough bacteria left for them to grow back after you ease the pressure on them. When you stop administering antibiotics, a week goes by, then you get sick again, and you think: when will this stop?” says Christian Lodberg Hvas.
Safety is paramount
FMT comprises capsules containing frozen and minimally processed faeces from healthy donors. It is a real transplant: one donor, one recipient. The researchers remove fluid, waste and indigestible residues and end up with 50 grams of faeces, which is then distributed among about 25 capsules that are double-sealed and specially manufactured to accommodate biological material and bring it safely to its destination in the recipient’s gut without the contents degrading.
But extremely strict safety requirements are imposed precisely because this involves transferring biological tissue – what the European Union calls substances of human origin.
“Transferring infectious microorganisms is a real risk, and in the United States multidrug-resistant bacteria have been transferred, with fatal outcomes, because guidelines were not followed. People will not make that mistake again,” explains Christian Lodberg Hvas.
In Denmark, faecal donors are recruited from healthy blood donors, and they undergo extensive screening – with blood tests, stool samples and questionnaires both before and after donation. The entire process is handled in a blood bank with a documentation system, registration and traceability if a donor later becomes ill. To ensure that diseases are not transmitted from the donors, both the donors and the patients are closely followed up for up to two years after FMT.
The need to spread awareness of FMT is largely an international task, which Denmark has helped to document in a European survey.
“Denmark can largely thank the collaboration between the hospitals and the blood bank for achieving such a great position to benefit people like Kirsten,” says Christian Lodberg Hvas, who adds that he initiated the studies after seeing many hospitalised people die despite the personnel doing everything in their power to save them. This opened his eyes to the good experiences obtained with similar initiatives in other countries.
This led him and his team to launch outpatient treatment for people who were dying at the Vikærgården rehabilitation centre in Aarhus in 2018. The initiative saved many people – a feat that triggered an article in Age & Ageing, an article in Transfusion and an article in The Lancet Regional Health.
