{"id":"rbx2660","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"RBX2660 is a rationally-designed, live biotherapeutic product containing a consortium of bacterial spores and vegetative cells derived from healthy donor stool. It restores a diverse and balanced gut microbiota, which competitively inhibits C. difficile colonization and toxin production. By reconstituting the protective microbial ecosystem, it addresses the underlying dysbiosis that predisposes patients to recurrent CDI.","oneSentence":"RBX2660 is a microbiota restoration therapy that repopulates the gut microbiome to treat recurrent Clostridioides difficile infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:22.203Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Recurrent Clostridioides difficile infection (rCDI)"}]},"trialDetails":[{"nctId":"NCT05831189","phase":"PHASE3","title":"A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2023-04-21","conditions":"Clostridium Difficile Infection Recurrence","enrollment":41},{"nctId":"NCT03931941","phase":"PHASE3","title":"Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)","status":"COMPLETED","sponsor":"Rebiotix Inc.","startDate":"2019-07-30","conditions":"Clostridium Difficile Infection, Infection, Communicable Diseases","enrollment":793},{"nctId":"NCT03244644","phase":"PHASE3","title":"Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)","status":"COMPLETED","sponsor":"Rebiotix Inc.","startDate":"2017-07-31","conditions":"Clostridium Difficile Infection (CDI)","enrollment":320},{"nctId":"NCT03378167","phase":"PHASE1","title":"PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial","status":"COMPLETED","sponsor":"McMaster Children's Hospital","startDate":"2018-12-01","conditions":"Crohn Disease, Pediatric Crohns Disease, Inflammatory Bowel Diseases","enrollment":17},{"nctId":"NCT03439982","phase":"PHASE1, PHASE2","title":"Fecal Transplant for Hepatic Encephalopathy","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2016-04-12","conditions":"Hepatic Encephalopathy","enrollment":3},{"nctId":"NCT03367910","phase":"PHASE1, PHASE2","title":"Fecal Microbiota Transplantation (FMT) for MDRO UTI","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2018-02-08","conditions":"Urinary Tract Infections","enrollment":1},{"nctId":"NCT02589847","phase":"PHASE2","title":"Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection","status":"COMPLETED","sponsor":"Rebiotix Inc.","startDate":"2015-10","conditions":"Clostridium Difficile Infection","enrollment":272},{"nctId":"NCT02299570","phase":"PHASE2","title":"Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection","status":"COMPLETED","sponsor":"Rebiotix Inc.","startDate":"2014-12","conditions":"Enterocolitis Clostridium Difficile Recurrent","enrollment":150},{"nctId":"NCT01925417","phase":"PHASE2","title":"Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea","status":"COMPLETED","sponsor":"Rebiotix Inc.","startDate":"2013-08","conditions":"Recurrent Clostridium Difficile Infection","enrollment":34},{"nctId":"NCT02487238","phase":"PHASE1","title":"Pediatric FEcal Microbiota Transplant for Ulcerative Colitis","status":"COMPLETED","sponsor":"McMaster Children's Hospital","startDate":"2015-11","conditions":"Inflammatory Bowel Disease, Ulcerative Colitis","enrollment":35}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":57,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["microbiota suspension","REBYOTA®","Microbiota suspension"],"phase":"phase_3","status":"active","brandName":"RBX2660","genericName":"RBX2660","companyName":"Rebiotix Inc.","companyId":"rebiotix-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"RBX2660 is a microbiota restoration therapy that repopulates the gut microbiome to treat recurrent Clostridioides difficile infection. Used for Recurrent Clostridioides difficile infection (rCDI).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}