Rebyota (fecal microbiota, live-jslm) / Ferring - LARVOL DELTA

Safety and Efficacy of Fecal Microbiota, Live-jslm for Prevention of Recurrent Clostridioides difficile Infection Among Hospitalized Participants in PUNCH CD3-OLS. (PubMed, Infect Dis Ther) - P3 | "RBL was safe and effective in a subgroup of hospitalized participants in the PUNCH CD3-OLS study. Efficacy in this subgroup was slightly lower than in nonhospitalized participants, but rCDI-related rehospitalization remained rare."

Journal • Infectious Disease

Patient-reported benefits of colonoscopicallyadministered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection. (PubMed, Therap Adv Gastroenterol) - P3 | "Fecal microbiota, live-jslm (RBL; REBYOTA®) is approved by the FDA to reduce CDI recurrence...These findings highlight the broader value of RBL in restoring HRQoL and overall well-being. ClinicalTrials.gov: NCT05831189."

Journal • Fatigue • Infectious Disease • Pain

ROAR: REBYOTA™ Prospective Registry (clinicaltrials.gov) - P=N/A | N=145 | Completed | Sponsor: Ferring Pharmaceuticals | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Aug 2025 | Trial primary completion date: Feb 2026 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

Fecal Microbiota Transplantation in 2025: Two Steps Forward, One Step Back. (PubMed, Curr Gastroenterol Rep) - "After decades of steady progress, the U.S. Food and Drug Administration (FDA) approved the first FMT-based therapies: fecal microbiota, live-jslm and fecal microbiota spores, live-brpk-in 2022 and 2023, respectively. Although first reported almost seventy years ago, extensive efforts over the last two decades have placed FMT in routine algorithms for many patients with CDI. While understanding of the intestinal microbiome's role in other gastrointestinal conditions is expanding, and FMT may modulate these pathways, additional evidence is needed before FMT becomes routine outside CDI."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. (PubMed, Therap Adv Gastroenterol) - P2, P2b, P3 | "Overall, data demonstrate RBL has a favorable 6-month safety profile. ClinicalTrials.gov: NCT01925417; NCT02299570; NCT02589847; NCT03244644; NCT03931941."

Journal • Infectious Disease

Diagnosis and Management of C. difficile. (PubMed, Am J Gastroenterol) - "Treatment paradigms are discussed across the spectrum of disease severity, with vancomycin and fidaxomicin as first-line therapies and the diminishing role of metronidazole. For recurrent CDI, newer fecal microbiota-based therapies, including Fecal Microbiota, live-jslm (Rebyota, RBL) and Fecal Microbiota Spores, live-brpk (Vowst, VOS), are reviewed. The role of conventional fecal microbiota transplantation (FMT), particularly in fulminant CDI, is also addressed, including challenges resulting from FDA policies around stool bank material. We aim to clarify diagnostic and therapeutic approaches and optimize care for patients with CDI."

Journal • Infectious Disease • Transplantation

Prevention of recurrent Clostridioides difficile infection by fecal microbiota, live-jslm (REBYOTA®) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial. (PubMed, Therap Adv Gastroenterol) - P3 | "RBL administered via colonoscopy was safe and effective for preventing CDI recurrence in adults with rCDI in CDI-SCOPE. ClinicalTrials.gov: NCT05831189."

Journal • P3 data • Gastrointestinal Disorder • Infectious Disease

Significant and Durable Microbiome Restoration in a Phase 3 Trial of Fecal Microbiota, Live-JSLM for Recurrent Clostridioides difficile Infection When Administered by Colonoscopy (ACG 2025) - P3 | "Overall, 41 received RBL via colonoscopy; 39 participants completed an 8-week visit, with a treatment success rate of 95%.There were 20 participants with a full stool sample timeline (baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 6 months) and 18 with a baseline sample and at least 1 post-administration sample. Compared with baseline, microbiome composition and MHI-A shifted significantly towards RBL composition among responders. Bacteroidia and Clostridia increased in abundance, whereas Gammaproteobacteria and Bacilli decreased following RBL administration via colonoscopy (Figure 1)."

P3 data • Infectious Disease

Comparison of the Efficacy and Safety of Live Fecal Microbiota Therapeutics for Recurrent Clostridioides difficile Infection (CDI): Matching-Adjusted Indirect Treatment Comparison in Patients With ≥1 CDI Recurrence (ACG 2025) - "The orally administered fecal microbiota spores, live-brpk (VOS) and rectally administered fecal microbiota, live-jslm (RBL), with different compositions, are both FDA-approved for any patients with rCDI. Of the 33 publications identified in the SLR, six, reporting on two distinct studies including patients with ≥1 recurrent episode were deemed eligible for the MAIC. VOS was significantly more efficacious than RBL in preventing rCDI at 8 weeks (odds ratio [OR]; 9.23 [95% confidence interval (CI): 4.24, 20.08]). The time to recurrence over time was significantly lower with VOS compared with RBL (hazard ratio; 0.19 [95% CI; 0.10, 0.33])."

Clinical • Infectious Disease

Long-Term Safety of Fecal Microbiota, Live-jslm Administered via Colonoscopy to Adults With Recurrent Clostridioides difficile Infection: 6-Month Safety Data From CDI-SCOPE, a Single-Arm, Phase 3b Trial (ACG 2025) - P3 | "Of the 41 participants, 39 completed follow-up through 6 months. From 8 weeks through 6 months after RBL administration, 36 additional TEAEs in 15 participants (36.6%) were reported, 1 of which (irritable bowel syndrome) was RBL-related. During this period, most TEAEs (97.2%) were of mild or moderate severity, and 1 serious, potentially life-threatening TEAE (worsening abdominal pain) unrelated to RBL was observed."

Clinical • P3 data • Gastrointestinal Disorder • Infectious Disease

Efficacy of Fecal Microbiota Transplant for Prevention of Recurrent CDI in Patients Diagnosed With Cancer (ACG 2025) - "Vancomycin and fidaxomicin were the most frequently used antibiotics, and 18.8% received bezlotoxumab.Colonoscopy-delivered FMT was the most common intervention (68.1%), followed by Rebyota (17.4%) and VOWST (7.2%); combination strategies were used in 7.2%. A total of 69 patients with a history of CDI or rCDI were included. Hematologic malignancies were the most common cancer type (29.6%), and nearly half had stage III–IV disease. At the time of their most recent CDI episode, 55% were receiving active cancer therapy."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Oncology • Transplantation

Evaluation of Fecal Microbiota, Live-jslm by Standard of Care Antibiotic Washout Period for the Prevention of Recurrent Clostridioides difficile Infection (ACG 2025) - "Of the 130 patients who received RBL, 99 patients were in Group 1 and 31 patients were in Group 2 (Table 1). The median days of washout period were 2 days in Group 1 and 9 days in Group 2 (p< 0.0001). The two groups had a similar median age (Group 1: 72; Group 2: 71), same median Charlson Comorbidity Index of 4.0, with female being the majority in both."

Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

Microbiome and metabolome changes after fecal microbiota, live-jslm, administration are associated with health-related quality of life improvements. (PubMed, Anaerobe) - P3 | "The microbiota-gut-brain axis is posited to modulate health-related quality of life, microbiome, and metabolome changes through immune, gastrointestinal, and central nervous system functions in patients with recurrent C. difficile infection following RBL administration. These analyses provide a novel approach for investigating multi-omics data and categorical health-related quality of life questionnaires and generate new insights for further clinical studies."

Clinical • HEOR • Journal • Infectious Disease

Microbiota-Based Therapies for Recurrent Clostridium difficile Infection: A Systematic Review of Their Efficacy and Safety. (PubMed, Cureus) - "Donor FMT outperformed autologous FMT (90.9% vs. 62.5%, p = 0.042) and standard therapies (71% resolution vs. 33% fidaxomicin/19% vancomycin, p < 0.01). Donor-derived interventions and pharmaceutical-grade products (SER-109, RBX2660) represent promising alternatives to traditional antibiotics, particularly in recurrent or refractory cases. Future research should aim to standardize protocols and include more high-risk populations."

Journal • Review • Infectious Disease • Transplantation

Real-World Effectiveness and Health-Related Quality of Life Improvements Using Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection (IDWeek 2025) - No abstract available

Clinical • HEOR • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease

Initial Results From a Real-World Patient Registry Study of Adults Receiving Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection: The RebyOtA Prospective Registry (ROAR) (IDWeek 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

Real-World Effectiveness and Health-Related Quality of Life Improvements Using Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection (IDWeek 2025) - No abstract available

Clinical • HEOR • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease

What's New and What's Next in Fecal Microbiota Transplantation? (PubMed, Biologics) - "In recent years, the FDA approved two standardized microbiota-based therapeutics-Rebyota™ (fecal microbiota, live-jslm) and Vowst™ (fecal microbiota spores, live-brpk)-for rCDI prevention. Meanwhile, regulatory pathways and clinical guidelines for microbiota-derived biologics and live biotherapeutic products continue to evolve. In this manuscript, we provide an update on the emerging use of FDA-approved prescription microbiota-derived therapeutics for the prevention of rCDI, review data on investigational agents including both donor dependent and donor independent microbial products, and summarize current evidence on the use of conventional FMT for indications beyond prevention of rCDI."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Transplantation

Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome. (PubMed, Infect Dis Ther) - P3 | "RBL is a safe and efficacious option to prevent CDI recurrence in patients with concurrent IBS."

Journal • Gastrointestinal Disorder • Infectious Disease • Pneumonia • Respiratory Diseases

Decreased Antimicrobial Resistance Gene Richness Following Fecal Microbiota, Live-jslm (REBYOTA®) Administration: Post Hoc Analysis of PUNCH CD3. (PubMed, Open Forum Infect Dis) - P3 | "These data support a model in which microbiota-based products, including RBL, may reduce antibiotic resistance gene richness, thereby possibly reducing the risk of antimicrobial-resistant organism infection. NCT03244644 (https://clinicaltrials.gov/study/NCT03244644; 9 August 2017)."

Journal • Retrospective data • Infectious Disease

Budget Impact Analysis of Fecal Microbiota Spores, Live-brpk (Formerly SER-109) for Recurrent Clostridioides difficile Infection in the United States. (PubMed, Infect Dis Ther) - "Treatment with VOS is anticipated to reduce recurrences and health plan costs for those with rCDI. Using VOS earlier is expected to increase cost savings. Graphical abstract available for this article."

HEOR • Journal • Infectious Disease

Clinician Management Preferences for Clostridioides difficile Infection in Adults: A 2024 Emerging Infections Network Survey. (PubMed, Open Forum Infect Dis) - "Additionally, 72% (357/498) reported that their institutional guidelines recommended vancomycin as the first-line agent. The most common barrier to fidaxomicin use was challenges with outpatient insurance coverage (82% [408/496]). Bezlotoxumab was available to 74% (370/500) of respondents, though 33% (165/497) indicated they do not use bezlotoxumab routinely...Fecal microbiota live-jslm was available to 36% (179/500), and fecal microbiota spores live-brpk was available to 30% (150/500). Significant barriers, including high costs, insurance challenges, and limited availability of CDI therapies, impact clinical decision-making and adherence to guideline recommendations."

Journal • Infectious Disease • Transplantation

Fecal microbiota transplantation: Current evidence and future directions. (PubMed, Cleve Clin J Med) - "Product development and standardization, such as the US Food and Drug Administration-approved live biotherapeutic products Rebyota and Vowst, are helping efforts to evaluate FMT for other gastrointestinal and extraintestinal diseases. However, additional clinical trials are needed to support its use beyond recurrent C difficile infection."

Journal • Review • Infectious Disease • Transplantation

Microbiome compositional changes and clonal engraftment in a phase 3 trial of fecal microbiota, live-jslm for recurrent Clostridioides difficile infection. (PubMed, Gut Microbes) - P3 | "Bacteroidia species were among the most effectively engrafted species from RBL. This study utilizes data from a large clinical trial to establish a method with high specificity for exploring clonal engraftment from microbiota-based treatments to facilitate future pharmacokinetic and pharmacodynamic analyses.Clinicaltrials Registration: NCT03244644."

Clinical • Journal • P3 data • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

Fecal microbiota transplantation: present and future. (PubMed, Clin Endosc) - "It has been proven to be highly effective in treating recurrent Clostridioides difficile infection (CDI), and United States Food and Drug Administration-approved microbiome-based therapies, such as REBYOTA (fecal microbiota live-jslm) and VOWST (fecal microbiota spores live-brpk), offer promising treatment options. Emerging therapies such as VE303 (Vedanta) are being studied to refine treatment approaches and expand the use of microbiota-based therapies. Further studies are needed to standardize guidelines, improve patient outcomes, and better define the role of FMT in the treatment of diseases beyond recurrent CDI."

Journal • Review • Infectious Disease • Metabolic Disorders • Transplantation