2023-05-05 09:07:00
This medical clearance is likely to cause debate and spark many conversations. After the transplantation of feces to restore the balance of bacteria in the gutthe Food and Drug Administration (the US Federal Food Agency) validated on April 26 the marketing ofa new oral treatment much easier to use and less invasive.
Fight the bad bacteria without destroying the good ones
Americans will soon be able to heal themselves thanks to the first orally administered faecal microbiota product, in other words capsules containing excrement extracts. A process derived from t fecal transplantation already used as a real treatment. Healthy bacteria from the stool donor help restore the balance of bacteria in the gut of the patient and thus helps to prevent reinfections. The microbiota transplant has already borne fruit. It is not new, the first trials in the West having been carried out in 1983. The first randomized clinical trial was launched in 2013. It is a real success.
This new drug is therefore inspired by fecal transplantation, it bears the name of Vowst. It can only be prescribed to adult patients to prevent recurrence of infection clostridioides difficile, a bacterium that causes severe diarrhea which can be associated with intestinal disorders such as colitis, inflammation of the colon. This bacterium is particularly resistant to antibiotics.
Plus, they can destroy healthy gut bacteria, making it even more more vulnerable to infection. A vicious circle which has as its first consequence superinfection. Antibiotics destroy the good bacteria and the gut becomes increasingly fragile, leaving more room for bad bacteria to grow. Pathology then becomes chronic.
A treatment that has certain risks
This new treatment was approved following several placebo-controlled clinical trials. A study was carried out to evaluate its effectiveness with 182 participants. Eight weeks following taking the treatment, recurrence of infection was lower in those who took Vowst (12.4%) than in those who took a simple placebo (39.8%).
Adverse effects have nevertheless been reported as abdominal swelling, constipation and diarrhoea.
Stool donors have of course undergone a panoply of tests in order to avoid the transmission of pathogens, but the FDA warns that the drug “may carry a risk of transmission of infectious agents.” It may also contain food allergens which depends on the food of the donors. However, it is impossible to control what donors eat. This treatment therefore has its limits, but it is the only one, with faecal transplantation, to be recognized effective once morest bacteria clostridioides difficile. Like transplantation, only infection with clostridioides difficile, allows the prescription of Vowst. This drug is not insignificant and remains a treatment to be used only in the most serious cases where no other solution is possible.
The French and European health authorities have not yet warned of a possible marketing authorization across the Atlantic.
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