ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02981316 (Treatment of Recurrent Clostridium Difficile Infection With RBX7455), which is not on this map. Cited by 35 papers.
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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.
Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
Who cites it
35 citing papers in PubMed.
- Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial.BMC infectious diseases · 2022Trial
- Microbiome-based therapeutics forGut microbes · 2026Review
- Immunotherapy restores therapeutic efficacy of fecal microbiome transplants to treatbioRxiv : the preprint server for biology · 2026Article
- Ecological and dietary strategies to constrain Clostridioides difficile.Cell host & microbe · 2026Review
- Transplantation of encapsulated fecal microbiota: research progress and future trends.World journal of pediatrics : WJP · 2026Review
- StrainFacts accurately quantifies both endogenous and live biotherapeutic product strain abundances in simulated and clinical vaginal microbiota samples.bioRxiv : the preprint server for biology · 2025Article
- Bioengineered Probiotics for Clostridioides difficile Infection: An Overview of the Challenges and Potential for This New Treatment Approach.Probiotics and antimicrobial proteins · 2025Review
- The evolving landscape of live biotherapeutics in the treatment of Clostridioides difficile infection.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025Review
- Fecal microbiota transplantation-current perspective on human health.Frontiers in medicine · 2025Review
- What's New and What's Next in Fecal Microbiota Transplantation?Biologics : targets & therapy · 2025Review
- Validation methods for encapsulated faecal microbiota transplantation: a scoping review.Therapeutic advances in gastroenterology · 2025Review
- Beyond Antibiotics: Novel Approaches in the Treatment of RecurrentACG case reports journal · 2024Article
- Multilevel Proteomic Profiling of Colorectal Adenocarcinoma Caco-2 Cell Differentiation to Characterize an Intestinal Epithelial Model.Journal of proteome research · 2024Article
- A Comparison of Currently Available and Investigational Fecal Microbiota Transplant Products for RecurrentAntibiotics (Basel, Switzerland) · 2024Review
- Future Therapies of Hepatic Encephalopathy.Clinics in liver disease · 2024Review
- Review
- Microbiota-Based Live Biotherapeutic Products forInfection and drug resistance · 2024Review
- Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Review
- Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention ofMicroorganisms · 2023Review
- ClostridioidesGastroenterology & hepatology · 2023Article
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6 authors.
Funding
Abstract
backgroundRecurrent Clostridioides difficile infections (rCDI) are a global public health threat. To reduce rCDI, microbiota-restoring therapies are needed, particularly standardized, easy-to-administer formulations.
methodsThis phase I open-label trial assessed the safety, efficacy in preventing rCDI recurrence, and intestinal microbiome effects of RBX7455, a room temperature-stable, orally administered investigational live biotherapeutic. Adult participants with 1 or more prior episodes of rCDI received: 4 RBX7455 capsules twice daily for 4 days (group 1); 4 RBX7455 capsules twice daily for 2 days (group 2); or 2 RBX7455 capsules twice daily for 2 days (group 3). For all groups, the first dose was administered in clinic, with remaining doses self-administered at home. Adverse events were monitored during and for 6 months after treatment. Treatment success was defined as rCDI prevention through 8 weeks after treatment. Participants' microbiome composition was assessed prior to and for 6 months after treatment.
resultsNine of 10 group 1 patients (90%), 8 of 10 group 2 patients (80%), and 10 of 10 group 3 patients (100%) were recurrence-free at the 8-week endpoint with durability to 6 months. Seventy-five treatment-emergent adverse events were observed in 27 participants with no serious investigational product-related events. Prior to treatment, participants' microbiomes were dissimilar from the RBX7455 composition with decreased Bacteroidia- and Clostridia-class bacteria, whereas after treatment, responders' microbiomes showed increased Bacteroidia and Clostridia.
conclusionsThree dosing regimens of RBX7455 were safe and effective at preventing rCDI. Responders' microbiomes converged toward the composition of RBX7455. These results support its continued clinical evaluation. CLINICAL TRIALS REGISTRATION: NCT02981316.
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