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

RATIONALLY DESIGNED SYNTHETIC MICROBIAL CONSORTIA VS. TRADITIONAL FECAL MICROBIOTA TRANSPLANTATION: A SYSTEMATIC COMPARISON OF CLINICAL OUTCOMES, ENGRAFTMENT SUCCESS, AND ADVERSE EVENTS IN ANTIBIOTIC-REFRACTORY GASTROINTESTINAL DISORDERS (UEGW 2026) - "Rationally designed synthetic microbial consortia offer comparable clinical efficacy to traditional FMT with superior standardization, predictable engraftment kinetics, and enhanced safety profiles through elimination of donor variability and pathogen transmission risks. FDA approval of SER-109 and RBX2660 establishes regulatory precedent for microbiome therapeutics. Future research should prioritize head-to-head RCTs, long-term durability beyond 6 months, optimization for immunocompromised populations, and expansion to refractory IBD indications."

Adverse events • Clinical • Clinical data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

Microbiome Restoration in Fulminant Clostridioides difficile Infection: A Case Series of Fecal Microbiota, Live-jslm for Refractory Disease (ACG 2026) - "He improved with oral vancomycin and intravenous metronidazole but deteriorated after transition to fidaxomicin, with worsening abdominal pain, leukocytosis, and imaging concerning for evolving toxic megacolon. The American Gastroenterology Association suggests microbiome restoration in select individuals not responding to guideline directed medical therapy given associated mortality. Prospective studies are needed to define patient selection, timing of standardized microbiome therapies, and long-term outcomes."

Clinical • Acute Kidney Injury • Gastrointestinal Disorder • Infectious Disease • Nephrology • Renal Disease

Adverse Event Profiles of Orally and Rectally Administered Fecal Microbiota Live Biotherapeutics for Recurrent Clostridioides difficile Infection: A Disproportionality Analysis of FAERS (ACG 2026) - "Two are FDA-approved: fecal microbiota, live-jslm, given rectally, and fecal microbiota spores, live-brpk, given orally. We identified 987 reports for the oral product and 229 for the rectal product. Both profiles were dominated by gastrointestinal and disease related events: diarrhea (oral 47.5%, rectal 35.8%), recurrent CDI (24.9% in both), abdominal pain, nausea, and drug ineffectiveness. Death was reported in 1.1% (oral) and 0.9% (rectal)."

Adverse events • Gastroenterology • Infectious Disease • Nephrology • Septic Shock • ROR1

Cost-effectiveness of Fecal Microbiota Spores, Live-brpk for the Prevention of Recurrent Clostridioides difficile Infection in the United States (ACG 2026) - "FDA-approved microbiome therapies fecal microbiota, live-jslm (RBL) and fecal microbiota spores, live-brpk (VOS), are available for prevention of rCDI. VOS at first recurrence was dominant (cost-saving and more effective) versus both SoC and RBL. Compared with SoC, VOS reduced total per-patient costs by $2,247 ($37,327 vs $39,574), averted 0.74 (0.53 vs 1.27) subsequent recurrences, and produced 0.07 additional QALY (net monetary benefit [NMB]: $9,431 at $100,000/QALY threshold). Compared with RBL, VOS reduced costs by $1,962, averted 0.41 recurrences, and produced 0.04 additional QALY (NMB: $5,927)."

Cost effectiveness • HEOR • Infectious Disease

Fecal Microbiota Transplantation in Refractory Immune Checkpoint Inhibitor-Induced Colitis (ACG 2026) - "Current National Comprehensive Cancer Network (NCCN) guidelines reserve FMT for patients who have failed initial corticosteroids, biologics including infliximab or vedolizumab, and additional agents such as tofacitinib or ustekinumab, or in whom such agents are contraindicated. Case Description/ A 70-year-old woman with metastatic melanoma was initiated on pembrolizumab 200 mg every 3 weeks...Her diarrhea remained refractory despite four tapering courses of prednisone and three doses of vedolizumab...Cholestyramine was briefly used for transient soft stool but discontinued due to constipation...Unlike traditional donor-derived FMT sourced from stool biorepositories, fecal microbiota, live-jslm offers a standardized and commercially available formulation that simplifies procurement and administration...While recent NCCN guidelines position FMT as salvage therapy, emerging data suggest that a single dose of FMT may induce steroid-free remission in a significant proportion..."

Checkpoint inhibition • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Melanoma • Oncology • Solid Tumor • Transplantation

A Novel Ecological Control and Optimization Model for Recurrent Clostridioides difficile Infection (ACG 2026) - "Fixed-protocol simulations reproduce Phase 3 RCT outcomes: SER-109 achieved 8-week recurrence of 12% versus 40% with placebo; pooled 24-week recurrence was 15.2%. REBYOTA demonstrated 70.6% treatment success versus 57.5% placebo at 8 weeks, with 90.5% sustained response at 6 months. Shannon diversity increased significantly by Week 1 with SER-109 (P< 0.001)."

Infectious Disease • Inflammation

Managing Refractory Immune Checkpoint Inhibitor-Induced Colitis With Oral Fecal Microbiota Transplantation: A Case Report (ACG 2026) - "We present a case of delayed-onset ICI colitis following prolonged pembrolizumab therapy, complicated by recurrent C.diff colonization, successfully managed with Vowst after failed multiple therapies...She received vancomycin (14 days) and nitazoxanide (7 days) without dramatic improvement...Vedolizumab was given, and a second Rebyota attempt failed due to high-volume diarrhea...Figure: Figure 2. Symptoms, laboratory exams, and treatment course including antibiotics, Rebyota and Vowst."

Case report • Checkpoint inhibition • Clinical • Breast Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Transplantation

Food and Drug Administration-Approved Fecal Microbiota-Based Therapies for Recurrent Clostridioides difficile Infection. (PubMed, Gastroenterol Clin North Am) - "Two Food and Drug Administration-approved donor-derived fecal microbiota-based products, fecal microbiota, live-jslm (Rebyota / RBL) and fecal microbiota spores, live-brpk (Vowst / VOS) reduce recurrence when administered after completion of standard antibiotics. We also discuss patient selection, timing after antibiotics, diagnostic considerations, and practical implementation. These therapies represent standardized, evidence-based approaches to restoring colonization resistance and preventing recurrent infection in appropriately selected adults."

Journal • Review • Infectious Disease • Transplantation

Post-Marketing Safety Signals of Microbiota-Based Live Biotherapeutic Products for Recurrent Clostridioides difficile Infection: A FAERS Pharmacovigilance Study. (PubMed, Am J Gastroenterol) - "FDA-approved LBPs demonstrate reassuring post-marketing safety profiles without transmitted infection signals. The extreme VOWST UTI signal is likely attributable to FDA-mandated expedited reporting obligations rather than a causal drug effect."

Adverse events • Journal • P4 data • Infectious Disease • Septic Shock • Transplantation • ROR1

AGA Clinical Practice Update on Management of Clostridioides difficile Infection in Adults: Expert Review. (PubMed, Clin Gastroenterol Hepatol) - "BEST PRACTICE ADVICE 5: Cholestyramine and other bile acid-binding agents should not be used as monotherapy or concurrently with oral vancomycin or fidaxomicin...BEST PRACTICE ADVICE 8: Fecal microbiota-based therapies (fecal microbiota spores, live-brpk, fecal microbiota, live-jslm, or conventional fecal microbiota transplant) should be offered after treatment of a second recurrence (third C difficile infection episode)...If a legitimate indication exists for their use, proton pump inhibitor discontinuation is not necessary. BEST PRACTICE ADVICE 14: Individuals with a history of C difficile infection should be specifically counseled to avoid unnecessary antibiotic therapy."

Clinical guideline • Journal • Critical care • Hepatology • Infectious Disease • Transplantation

Cost-effectiveness of Microbiota Restoration Therapies for Recurrent Clostridioides difficile Infection. (PubMed, Am J Gastroenterol) - "Earlier initiation of microbiota-based therapies after the first CDI recurrence provides greater health benefits at acceptable cost-effectiveness thresholds compared with delayed use, supporting earlier integration into rCDI treatment strategies. VOS-versus-RBL comparisons should be interpreted as exploratory indirect comparisons pending comparative real-world or head-to-head data."

HEOR • Journal • Infectious Disease

Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. (PubMed, Infect Dis Ther) - P2, P2b, P3 | "TRIAL REGISTRATION: ClinicalTrials.gov. NCT01925417; NCT02299570; NCT02589847; NCT03244644; NCT03931941; NCT05831189."

Journal • Review • Infectious Disease

AGA Clinical Practice Update on Management of Clostridioides difficile Infection in Inflammatory Bowel Disease: Expert Review. (PubMed, Gastroenterology) - "BEST PRACTICE ADVICE 4: In patients with IBD who develop an initial episode of CDI, clinicians should preferentially use fidaxomicin or use vancomycin if fidaxomicin is unavailable or cost-prohibitive...BEST PRACTICE ADVICE 9: Clinicians may consider loperamide in patients with improving inflammation and infection but ongoing diarrhea. BEST PRACTICE ADVICE 10: Clinicians should offer microbiome-based therapies (eg, fecal microbiota, live-jslm, fecal microbiota spores, live-brpk, or unapproved fecal microbiota transplantation) to patients with IBD with at least 1 recurrence of CDI to prevent future infection. BEST PRACTICE ADVICE 11: In patients with IBD, clinicians should not advise probiotics for primary or secondary prevention of CDI. BEST PRACTICE ADVICE 12: In patients with IBD and a history of CDI who are receiving systemic antibiotics, clinicians may consider oral vancomycin prophylaxis as secondary prevention."

Clinical guideline • Journal • Crohn's disease • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pain • Septic Shock • Transplantation • Ulcerative Colitis

Newer Therapeutics to Selectively Kill Clostridioides difficile and Restore the Microbiome. (PubMed, Infect Dis Rep) - "The results on ibezapolstat efficacy are promising, but require confirmation in larger patient populations through double-blind, randomised phase III trials. In the near future, an integrated approach may enhance the management of Clostridioides difficile infection: starting with highly specific antibiotics, i.e., ibezapolstat, followed by microbiome-based therapies such as live-JSLM."

Journal • Review • Infectious Disease • Transplantation

Clinical applications of live biotherapeutics: Current trends and future prospects. (PubMed, Prog Mol Biol Transl Sci) - "The most important advancement is in the infectious disease domain, where fecal microbiota transplantation validated ecological restoration for recurrent Clostridioides difficile infection and paved the way for the first approved LBPs (REBYOTA® and VOWST™/SER-109). Translation from benchside to bedside, however, is fraught with hurdles-variable patient response, manufacturing consistency, safety standards, cost, and ethics-exacerbated by heterogeneous global regulations, underscoring the need for harmonization. Precision microbial consortia, programmable "living medicines," and biohybrid formulations could extend LBPs into broader indications and global health, shifting practice toward an ecological model of therapeutics."

Journal • Review • Allergy • Immunology • Infectious Disease • Metabolic Disorders • Oncology • Transplantation

Live biotherapeutics in the clinic: Regulatory pathways, market dynamics, and future trends. (PubMed, Prog Mol Biol Transl Sci) - "The approvals of Rebyota and Vowst for recurrent Clostridioides difficile infection mark a pivotal milestone, establishing LBPs as a new therapeutic class. Progress, however, is tempered by manufacturing complexity, regulatory burden, reimbursement challenges, public perception, and incomplete mechanistic understanding. Despite these hurdles, the future is compelling, marked by expanding indications, engineered strains, standardized consortia, scalable manufacturing, regulatory harmonization, and accelerating investment."

Journal • Review • Infectious Disease • Metabolic Disorders • Oncology

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