(ORDO NEWS) — US Food and Drug Administration (FDA) for the first time approved treatment using donor human excrement. The drug, called Rebiota, contains gut bacteria collected from the stool of healthy donors and is approved to prevent a potentially life-threatening bacterial infection.
By injecting fluid into a patient’s rectum through a tube, doctors can help rebalance their gut microbiome, a community of microbes that live in the lower digestive tract.
Rebiota is approved for use in people 18 years of age and older who have recently been treated for recurrent infections caused by the bacterium Clostridium difficile , commonly referred to as C. diff for short . C. diff can quickly take over the gut if the normal microbiome is disrupted, such as after antibiotic use.
People aged 65 and older and those with weakened immune systems are most at risk of infection. As C. diff multiplies in the gut, the bacteria release toxins that cause diarrhea, abdominal pain, fever, and inflammation of the colon (colitis). According to the FDA, sometimes infections can lead to organ failure and even death.
Researchers estimate that C. diff causes about half a million infections in the US each year, and about one in six patients is at risk of re-infecting within two to eight weeks of recovery.
Such recurrent infections can be treated with antibiotics, but the drugs do not always work against aggressive, antibiotic-resistant strains of C. diff , and what’s more, they can further disrupt the microbiome and sometimes exacerbate the infection. To uncover the root cause of the problem – an imbalanced gut microbiome – doctors are increasingly turning to so-called fecal microbiota transplants.
Previously considered an “exploratory” treatment by the FDA, these transplants involve transferring verified donor stool into the patient’s intestines via colonoscopy, enema, or pills. But now, researchers say, Rebiota reduces the rate of C. diff flare-ups by 29.4% for eight weeks after antibiotic treatment compared to placebo.
Taking into account the two clinical trials of the treatment, the treatment success rate was significantly higher in the Rebiota group (70.6%) than in the placebo group (57.5%), the FDA noted.
“Today’s approval of Rebiota is a step forward in the care of patients with recurrent C. difficile infection. As the first FDA-approved fecal microbiota product, this represents an important milestone as it opens up an additional option for preventing re-infection,” Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.
In clinical trials, the most common side effects of Rebiota were abdominal pain, diarrhea, bloating, gas, and nausea. And while donated feces are carefully screened for pathogens, treatment carries some risk of transmitting infectious agents and may also contain food allergens, the FDA said in a statement.
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