Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
PUNCH CD3-OLS: A Phase 3 Prospective Observational Cohort Study to Evaluate the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) in Adults With Recurrent Clostridioides difficile Infection.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03931941 (A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety and efficacy of fecal microbiota transplantation versus antibiotics for treating clostridioides difficile infection: systematic review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Pooled it
- Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS.Inflammatory bowel diseases · 2025Trial
- Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing RecurrentOpen forum infectious diseases · 2025Trial
- Synthetic microbial communities: emerging live biotherapeutics for targeted gut microbiome modulation.Gut microbes · 2026Review
- The role of gut microbiome in aging-associated diseases: where do we stand now and how technology will transform the future.Gut microbes · 2026Review
- Evaluation of fecal microbiota, live (RBL) for the prevention of recurrentJournal of the Canadian Association of Gastroenterology · 2026Article
- Gut microbiota-targeted interventions for depression in adolescents and young adults: Mechanisms, evidence strength and clinical strategies-A narrative review.General psychiatry · 2026Review
- Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies.Infectious diseases and therapy · 2026Review
- Newer Therapeutics to Selectively KillInfectious disease reports · 2026Review
- Attenuated Bacteria-Based Tumor Therapy: Clinical Application Risks, Marketing Approval Restrictions, and Coping Strategies.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Safety and Efficacy of Fecal Microbiota, Live-jslm for Prevention of Recurrent Clostridioides difficile Infection Among Hospitalized Participants in PUNCH CD3-OLS.Infectious diseases and therapy · 2026Article
- Fecal microbiota transplantation: from empirical remedy to precision medicine.Frontiers in microbiomes · 2026Review
- Design and application of synthetic human gut microbial communities.Gut microbes · 2025Review
- Microbiome Therapeutics for Clostridioides difficile Infection.Infectious disease clinics of North America · 2025Review
- Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome.Infectious diseases and therapy · 2025Article
- Targeting SleC and CspB in the Inhibition of Spore Germination inJournal of medicinal chemistry · 2025Article
- What's New and What's Next in Fecal Microbiota Transplantation?Biologics : targets & therapy · 2025Review
- Prevention of recurrentTherapeutic advances in gastroenterology · 2025Article
- Safety and effectiveness of fecal microbiota, live-jslm (REBYOTATherapeutic advances in gastroenterology · 2025Article
- Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrentTherapeutic advances in gastroenterology · 2025Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundThe aim of this study was to evaluate the safety and efficacy of fecal microbiota, live-jslm (RBL; REBYOTA)-the first single-dose, broad consortia microbiota-based live biotherapeutic approved by the US Food and Drug Administration for preventing recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care (SOC) antibiotic treatment.
methodsPUNCH CD3-OLS was a prospective, phase 3, open-label study, conducted across the US and Canada. Participants were aged ≥18 years with documented rCDI and confirmed use of SOC antibiotics. Participants with comorbidities including inflammatory bowel disease and mild-to-moderate immunocompromising conditions could be enrolled. A single dose of RBL was rectally administered within 24-72 hours of antibiotic completion. The primary endpoint was the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs). Secondary endpoints included treatment success and sustained clinical response, at 8 weeks and 6 months after RBL administration, respectively.
resultsOverall, 793 participants were enrolled, of whom 697 received RBL. TEAEs through 8 weeks after administration were reported by 47.3% of participants; most events were mild or moderate gastrointestinal disorders. Serious TEAEs were reported by 3.9% of participants. The treatment success rate at 8 weeks was 73.8%; in participants who achieved treatment success, the sustained clinical response rate at 6 months was 91.0%. Safety and efficacy rates were similar across demographic and baseline characteristic subgroups.
conclusionsRBL was safe and efficacious in participants with rCDI and common comorbidities. This is the largest microbiota-based live biotherapeutic study to date, and findings support use of RBL to prevent rCDI in a broad patient population. CLINICAL TRIALS REGISTRATION: NCT03931941.
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