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Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from
Teena Chopra1, Daniel Van Handel2, Brian Baggott3
1Wayne State University, 4201 St Antoine, UHC-4G, Detroit, MI, 48201, USA. tchopra@med.wayne.edu.
Abstract:
Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections in the US, and recurrence remains a major clinical challenge, as standard-of-care antibiotics fail to prevent recurrence in up to one-third of cases. Fecal microbiota, live-jslm (RBL) is the first single-dose, microbiota-based product approved by the US Food and Drug Administration and Health Canada for the prevention of recurrent CDI (rCDI) following standard-of-care antibiotics. The RBL clinical development program is the largest to date for any microbiota-based product, encompassing seven studies and enrolling over 1700 participants to evaluate the safety and efficacy of RBL in preventing rCDI. Although the RBL development program consistently evaluated both efficacy and safety outcomes across all studies, this review summarizes the study designs, with a primary focus on the efficacy outcomes. The program consists of randomized controlled trials, open-label cohorts, retrospective analyses, and real-world data, each contributing unique insights across different patient populations and treatment settings. All studies enrolled adults aged ≥ 18 years with rCDI who received antibiotics for their enrolling CDI episode before RBL administration. Most studies administered RBL rectally, except for an open-label study and a retrospective study, which evaluated colonoscopic administration of RBL. Treatment success was evaluated at 8 weeks, and sustained clinical response was evaluated at 6 or 24 months after RBL and/or placebo administration, depending on the study design. Overall, the study designs for all seven studies were consistent, with slight differences between number of CDI episodes (specifically, 2 studies allowed enrollment after the first CDI recurrence), blinding, controls, and administration routes. Efficacy data of RBL reported across all studies consistently demonstrated RBL is efficacious for the prevention of rCDI in a broad adult population. TRIAL REGISTRATION: ClinicalTrials.gov. NCT01925417; NCT02299570; NCT02589847; NCT03244644; NCT03931941; NCT05831189.
Insights
Fecal microbiota, live-jslm (RBL) is a novel treatment that effectively prevents recurrent Clostridioides difficile infection (CDI) in adults. This microbiota-based therapy offers a promising solution for a common and challenging healthcare-associated infection.
Area of Science:
- Microbiology
- Gastroenterology
- Infectious Diseases
Background:
- Clostridioides difficile infection (CDI) is a significant healthcare-associated infection in the US.
- Recurrent CDI (rCDI) poses a major clinical challenge, with standard antibiotics failing in up to one-third of cases.
- Fecal microbiota, live-jslm (RBL) is the first FDA- and Health Canada-approved single-dose microbiota-based product for preventing rCDI.
Purpose of the Study:
- To review the study designs of the RBL clinical development program, focusing on efficacy outcomes.
- To summarize the safety and efficacy of RBL in preventing rCDI across seven studies.
- To present a comprehensive overview of the largest microbiota-based product development program to date.
Main Methods:
- The RBL program comprised seven studies, including randomized controlled trials, open-label cohorts, retrospective analyses, and real-world data.
- Studies enrolled adults (≥18 years) with rCDI who received antibiotics prior to RBL administration.
- Efficacy was assessed by treatment success at 8 weeks and sustained clinical response at 6 or 24 months; administration was primarily rectal, with some colonoscopic evaluations.
Main Results:
- The RBL development program enrolled over 1700 participants across seven diverse studies.
- Study designs were largely consistent, with minor variations in CDI episode counts, blinding, controls, and administration routes.
- Consistent efficacy data across all studies demonstrated RBL's effectiveness in preventing rCDI in a broad adult population.
Conclusions:
- The RBL clinical development program provides robust evidence for the efficacy of RBL in preventing recurrent CDI.
- RBL represents a significant advancement in managing rCDI, offering a successful alternative to standard antibiotic treatments.
- The comprehensive data from this large-scale program support the use of RBL for rCDI prevention in adults.
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