{"id":"ecn-suspension","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug consists of a non-pathogenic, genetically modified strain of E. coli that colonizes the intestinal tract and produces therapeutic metabolites or antigens. By restoring beneficial bacterial populations and promoting local and systemic immune tolerance, it aims to treat inflammatory and immune-mediated conditions. The suspension formulation allows oral delivery of viable bacterial cells to the gastrointestinal tract.","oneSentence":"EcN-Suspension is a live biotherapeutic containing engineered Escherichia coli Nissle 1917 designed to modulate the gut microbiome and immune system.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:10:33.131Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions"}]},"trialDetails":[{"nctId":"NCT05377112","phase":"EARLY_PHASE1","title":"Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome","status":"COMPLETED","sponsor":"Synlogic","startDate":"2022-03-29","conditions":"Enteric Hyperoxaluria","enrollment":11},{"nctId":"NCT02802059","phase":"PHASE3","title":"E. Coli Nissle 1917 - Suspension for Infection Prophylaxis","status":"COMPLETED","sponsor":"Ardeypharm GmbH","startDate":"2015-10-07","conditions":"Infections","enrollment":567},{"nctId":"NCT02706184","phase":"PHASE3","title":"E. Coli Nissle in Oncology","status":"COMPLETED","sponsor":"University of Hohenheim","startDate":"2015-07","conditions":"Gastric Cancer, Colorectal Cancer","enrollment":20},{"nctId":"NCT01540162","phase":"","title":"Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement","status":"COMPLETED","sponsor":"Odessa National Medical University","startDate":"2011-03","conditions":"Neonatal Infection","enrollment":62},{"nctId":"NCT01469273","phase":"PHASE4","title":"Prophylaxis of Gastrointestinal Infections With EcN","status":"UNKNOWN","sponsor":"Hospital San Bartolome","startDate":"2011-11","conditions":"Infantile Diarrhea","enrollment":198}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["E. coli strain Nissle 1917 bacteria"],"phase":"phase_3","status":"active","brandName":"EcN-Suspension","genericName":"EcN-Suspension","companyName":"Ardeypharm GmbH","companyId":"ardeypharm-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EcN-Suspension is a live biotherapeutic containing engineered Escherichia coli Nissle 1917 designed to modulate the gut microbiome and immune system. Used for Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}