Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Summary

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Timeline

Start

2015-10

Primary completion

2017-06

Completion

2019-03

Outcome

Met primary endpoint

paper RBX2660 demonstrated a 78.9% (112/142) treatment success rate compared to a 30.7% (23/75) for the historical control group (p < 0.0001; Chi-square test). PMID 35279084 ↗

Publications

• Chopra T, Van Handel D, Baggott B, Orenstein R, Reveles K, Guthmueller B, Srivastava S, Khanna S. Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. Infect Dis Ther. 2026 Aug;15(8):2071-2086. doi: 10.1007/s40121-026-01374-9. Epub 2026 Jun 12.
• Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Ther Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.
• Reveles KR, Gonzales-Luna AJ, Golan Y, Alonso CD, Guthmueller B, Tan X, Bidell MR, Pokhilko V, Crawford CV, Skinner AM. Efficacy of Fecal Microbiota, Live-jslm (REBYOTA(R)), Among Patients Exposed to Non-Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study. Open Forum Infect Dis. 2024 Jun 17;11(7):ofae341. doi: 10.1093/ofid/ofae341. eCollection 2024 Jul.
• Orenstein R, Dubberke ER, Khanna S, Lee CH, Yoho D, Johnson S, Hecht G, DuPont HL, Gerding DN, Blount KF, Mische S, Harvey A. Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial. BMC Infect Dis. 2022 Mar 12;22(1):245. doi: 10.1186/s12879-022-07256-y.

Drugs

Indications