ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

Summary

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.

Timeline

Start

2017-07-10

Primary completion

2020-07-03

Completion

2020-09-29

Outcome

Met primary endpoint

registry analysis (superiority test); SER-109 vs Placebo; p <0.001; Risk Ratio (RR) 0.32 (95% CI 0.18 to 0.58) NCT03183128 ↗

paper The percentage of patients with recurrence of C. difficile infection was 12% in the SER-109 group and 40% in the placebo group PMID 35045228 ↗

Publications

• Bryant JA, Vulic M, Walsh EA, Allen EG Jr, Beauchemin NJ, Chafee ME, Diao L, Fenn K, Ford KA, Hasson BR, Litcofsky KD, Lombardo MJ, Martinez A, O'Brien EJ, Straub TJ, Sykes SM, Marshall LF, Winkler JA, McGovern BH, Ford CB, Wortman JR, Henn MR. The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome. Nat Med. 2026 Jan;32(1):186-196. doi: 10.1038/s41591-025-04076-w. Epub 2026 Jan 5.
• Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
• Garey KW, Jo J, Gonzales-Luna AJ, Lapin B, Deshpande A, Wang E, Hasson B, Pham SV, Huang SP, Reese PR, Wu H, Hohmann E, Feuerstadt P, Oneto C, Berenson CS, Lee C, McGovern B, vonMoltke L. Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253570. doi: 10.1001/jamanetworkopen.2022.53570.
• Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Aunins JG, McChalicher CWJ, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022 Jan 20;386(3):220-229. doi: 10.1056/NEJMoa2106516.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SER-109	Other / unclassified	4 unknown	Oral

Indications