FDA Approves First Pill for the Microbiome

Probiotics have long been star ingredients in dairy foods, drinks, and supplements, promising to generate a better bacterial balance to our guts. On Apr. 26, the U.S. Food and Drug Administration (FDA) took a step toward formalizing the idea of adjusting gut-bacteria populations when it approved the first oral drug designed to treat the microbiome. Called SER-109, the pill is a cocktail of bacteria that can prevent recurring infections of C. difficile bacteria in people who have had previous episodes, and help them maintain healthy levels of gut bacteria. Keeping beneficial bacteria in proper balance could be an important way to keep disease-causing ones like C. difficile at bay. [time-brightcove not-tgx=”true”] The FDA based its decision on clinical trials that the drug’s maker, Seres Therapeutics, conducted in collaboration with Nestle Health Science in nearly 200 people who had had recurring C. diff infections. These infections spread easily in hospitals and are challenging to treat, since many of the bacteria are now resistant to antibiotics. According to the U.S. Centers for Disease Control and Prevention (CDC), about one in six people who have had a C. difficile infection will have another one in two to eight weeks. About 156,000 infections occur in the U.S. each year, causing diarrhea, cramping, dehydration, and fever. Between 15,000 and 16,000 people die from C. diff annually. In studies on which the approval was based, people took four capsules of S...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Drugs healthscienceclimate Source Type: news