There's a new medication that has been approved by the Food and Drug Administration for consumers to use to fight Clostridioides difficile, a serious intestinal infection that can be life-threatening.
And it's made from donated fecal material from qualified individuals.
"Today's approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection," explained Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
"The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening."
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The bacterium that causes the ailment is associated with up to 30,000 deaths a year.
"The human intestinal tract contains millions of microorganisms, often referred to as the 'gut flora,' or 'gut microbiome.' Certain situations, such as taking antibiotics to treat an infection, may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death," the FDA explained.
The announcement explained the dosage is four capsules taken once a day, orally, for consecutive days.
It "contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals."
The drug was tested in a "randomized, double-blind, placebo-controlled, clinical study and an open-label clinical study conducted in the U.S. and Canada."
https://www.wnd.com/2023/05/fda-approves-medicine-made-fecal-material/
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