US approves drug made from human feces to treat infections

Last week, The United States Food and Drug Administration (FDA) has announced the approval of the first product made from plants. stool microbiota🇧🇷 O rebytaunder its own name, it was developed by Ferring Pharmaceutical to treat infections due to the bacteria Clostridium difficile (CDI).

The live biotherapeutic product is indicated for persons over 18 years of age and should be administered after antibiotic therapy – only in persons with recurrent infections, as it is not indicated after initial infection with C. difficile. The bacteria can cause inflammation of the large intestine that results in severe diarrhea, but symptoms also include fever and abdominal pain – in more complex cases, the infection can lead to death.

Rebyota was developed from the feces of qualified and tested donors.🇧🇷 The application process by injecting 150 ml of healthy bacteria into the anus of a patient infected with C. difficile in a single dose through a tube can also be called “stool transplant”.

“Today’s approval of Rebyota is a milestone in the treatment of patients with recurrent C. difficile infections. Recurrent CDI affects an individual’s quality of life and can be potentially fatal. “As the first FDA-approved fecal microbiota product, today’s action represents an important milestone as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, Director of the FDA’s Center for Biological Evaluation and Research.

stool microbiota

The pharmaceutical company has conducted two randomized, double-blind, and placebo-controlled clinical trials in addition to open clinical trials to confirm the product’s safety. Within eight weeks, they were able to cure C. difficile infections in many of the patients they tested – 57.5% of those who took placebo and 70.6% of those who took Rebyota.

C. difficile bacteria can cause problems in different situations, depending on the health of the patient’s intestinal flora. For example, sometimes taking antibiotics upsets the balance of living microorganisms in our gut, giving space for bacteria to multiply and release toxins.