Investigational oral live microbiome therapeutic superior to placebo in patients with three or more episodes of C. difficile<\/em> infection<\/p>\n<\/h3>\n <\/b><\/p>\n <\/b><\/p>\n MONDAY, Jan. 24, 2022 (HealthDay News) — An investigational microbiome therapeutic composed of purified Firmicutes spores, SER-109, is superior to placebo for treatment of recurrent Clostridioides<\/em> difficile<\/em> infection, according to a study published in the Jan. 20 issue of the New England Journal of Medicine<\/em>.<\/p>\n Paul Feuerstadt, M.D., from the Yale University School of Medicine in New Haven, Connecticut, and colleagues conducted a phase 3, double-blind, randomized trial involving patients who had three or more episodes of C. difficile<\/em> infection. One hundred eighty-two patients were enrolled and randomly assigned to either SER-109 or placebo after standard-of-care antibiotics.<\/p>\n The researchers found that 12 and 40 percent of patients had recurrence of C. difficile<\/em> infection in the SER-109 and placebo groups, respectively (relative risk, 0.32) at up to eight weeks of follow-up. In analyses stratified according to age stratum, SER-109 led to less frequent recurrence than placebo (relative risks, 0.24 and 0.36 for those younger than 65 years of age and 65 years and older, respectively); results were similar in analyses stratified according to antibiotic received (relative risks, 0.41 and 0.09 for vancomycin and fidaxomicin, respectively). The number of adverse events, which were mostly mild-to-moderate and gastrointestinal in nature, was similar in the two groups. As early as week 1, SER-109 dose species were detected; they were associated with bile-acid profiles known to inhibit C. difficile <\/em>spore germination.<\/p>\n “The lower incidence of recurrence achieved with SER-109 administered after treatment with standard-of-care antibiotics represents a 68 percent lower risk than that with antibiotics alone and a number needed to treat of 3.6 to avoid one recurrence of C. difficile<\/em> infection,” the authors write.<\/p>\n The study was funded by Seres Therapeutics, the developer of SER-109.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n