The pharmaceutical-grade version of the fecal transplant can treat difficult intestinal infections.
. As long as stool donors are carefully screened for any potential infectious diseases, the FDA has rarely intervened in using the]is procedure.The approved treatment is administered through the rectum in a a single dose. It is prepared from stool donated by qualified individuals, all of whom are tested for a panel of transmissible pathogens.
Rebyota’s safety was assessed from two randomized, double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the US and in Canada. In the studies, 70 percent of patients taking Rebyota had their symptoms resolved after eight weeks, compared with 58 percent of patients who received a placebo.
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FDA clears 1st fecal transplant treatment for gut infectionU.S. officials approved the first pharmaceutical-grade version of the fecal transplant procedures that doctors have increasingly used to treat a potentially life-threatening intestinal infection. kprc2 click2houston fda health
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