The healing powers of poo can now officially come in a more palatable pill. This week, the Food and Drug Administration approved Fost, an oral capsule filled with beneficial bacteria derived from human feces. The drug is intended for the treatment of recurrent infections Clostridium difficile By balancing the gut microbiome.
While some bacteria and other microorganisms make us sick on a regular basis, our bodies are full of many harmless or even beneficial ones. The environments in which these passenger microbes live are called the microbiome, and the gut microbiome is thought to be particularly important to our health. There’s still a lot we don’t understand about the gut microbiome. But we do know that people can be more likely to develop health problems when the mix of bacteria in their gut is altered in some way by things like antibiotic treatment, including Jim hard infections.
These bacteria become abundant in the intestines and release toxins that cause symptoms such as diarrhea, abdominal pain, and fever. Although the infection can be treated with antibiotics, the bacteria often return quickly enough, causing a recurrence Jim hard. It is believed that approximately half a million Americans suffer from this infection annually, according to the Centers for Disease Control and PreventionAnd about one in six experience recurrent seizures. Infection occurs most commonly in hospitals and can be very serious for a higher risk Groups such as the elderly or immunocompromised.
Scientists have shown that it is possible to effectively reset a person’s gut microbiome by transplanting directly over the tube of a healthy donor – a procedure known as fecal microbiome transplantation (FMT). Scientists are still trying to find it Best uses For the treatment of FMT, however, it appears to be particularly effective in stopping recurrences Jim hard.
are still there Many challenges To make FMT treatment accessible and feasible. This includes the discomfort potential patients may feel when undergoing it The implantation is usually done by enema or colonoscopy. But some scientists are testing whether you can still get the benefits of FMT from people taking capsules containing these donated bacteria instead. On Wednesday, the US Food and Drug Administration approved the first such treatment for commercial use: Vowst, which was developed by Seres Therapeutics Inc and Nestlé Health Science.
Today’s approval provides patients and healthcare providers with a new way to help prevent recurrences Jim hard infection,” said Peter Marks, director of the Food and Drug Administration’s Center for Biology Evaluation and Research, in a statement statement. “The availability of an oral fecal microbiota product is an important step forward in enhancing patient care and access for individuals who have experienced this potentially life-threatening disease.”
The drug was approved on the basis of two studies conducted in the United States and Canada, including a randomized, double-blind, placebo-controlled trial. In this trial, those who were treated with Vowst were less likely to have another seizure than Jim hard after antibiotic treatment compared to the placebo group for the next 8 weeks (12.4% compared to 39.8%).
Common side effects associated with treatment in these studies included flatulence, fatigue, constipation, chills, and diarrhea. Donors are pre-screened for potentially harmful germs, but the Food and Drug Administration notes that Vowst may still pose an infection risk. The treatment can also contain potential allergens, but its actual risk of causing allergic reactions is not known at this time.
Vowst is approved for people over the age of 18 and is intended to be used alongside antibiotics to prevent recurrences. Jim hard infections. Four capsules are taken daily for three days. Manufacturers plan to apply for regulatory approval in Canada as well.