The effect of a microbial ecosystem therapeutic (MET-2) on recurrent Clostridioides difficile infection: A phase 1, open-label, single-group trial
The Lancet: Gastroenterology & Hepatology — Kao D, Wong K, Franz R, et al. | February 25, 2021
Although highly effective for recurrent Clostridioides difficile infection, fecal microbiota transplantation (FMT) has inherent risks. Researchers here evaluated the activity, safety, and tolerability of Microbial Ecosystem Therapeutic 2 (MET-2), an oral encapsulated formulation of 40 lyophilised bacterial species initially isolated from stool of a healthy donor, but manufactured independently of donors. In this phase 1, open-label, single-group feasibility study, they included 19 patients with mild to moderate C difficile infection and at least one episode of recurrence (ie, two episodes of C difficile infection) within 12 months. Participants' initial daily treatment was ten oral capsules for 2 days, then three capsules for 8 days. A higher dose was offered in cases with C difficile infection recurrence: 20 capsules for 2 days, then three capsules for 8 days. MET-2 treatment resulted in significant improvement in quality of life as well as alpha diversity in stool microbial composition. After treatment, most patients exhibited MET-2 associated taxa in greater abundance compared with baseline. By day 130, 16 (84%) of 19 patients did not have recurrence of C difficile infection. Overall findings support the safety, efficacy, and good tolerability of MET-2 among patients with recurrent C difficile infection.