{"id":"e-coli-nissle-suspension","safety":{"commonSideEffects":[{"rate":null,"effect":"Mild gastrointestinal symptoms (bloating, gas)"},{"rate":null,"effect":"Abdominal discomfort"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"E. coli Nissle 1917 is a non-pathogenic, commensal strain of E. coli that produces antimicrobial compounds, competes with pathogenic bacteria for nutrients and adhesion sites, and stimulates intestinal barrier function and local immune responses. It has been used clinically to maintain remission in ulcerative colitis and to support overall gut health by restoring beneficial microbiota composition.","oneSentence":"E. coli Nissle is a live biotherapeutic probiotic strain that colonizes the gut and modulates the intestinal microbiota and immune system to promote gastrointestinal health.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:35:56.665Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Maintenance of remission in ulcerative colitis"},{"name":"Traveler's diarrhea prevention"},{"name":"General gastrointestinal health and microbiota support"}]},"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":"NCT04608851","phase":"PHASE4","title":"Preventing Urinary Tract Infections With E. Coli Nissle:","status":"UNKNOWN","sponsor":"University of Oulu","startDate":"2021-01-18","conditions":"Urinary Tract Infections in Children, Secondary Prevention","enrollment":530},{"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":"NCT03800147","phase":"NA","title":"Effects of Nutritional Fat on the Growth of Intestinal E. Coli","status":"UNKNOWN","sponsor":"University of Zurich","startDate":"2019-01-24","conditions":"Escherichia Coli Infections","enrollment":40},{"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":"NCT02144948","phase":"PHASE3","title":"Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II","status":"COMPLETED","sponsor":"GWT-TUD GmbH","startDate":"2014-08","conditions":"Diabetes Mellitus Type II","enrollment":10},{"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":16,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Mutaflor Suspension®","Mutaflor"],"phase":"marketed","status":"active","brandName":"E. coli Nissle suspension","genericName":"E. coli Nissle suspension","companyName":"University of Hohenheim","companyId":"university-of-hohenheim","modality":"Small molecule","firstApprovalDate":"","aiSummary":"E. coli Nissle is a live biotherapeutic probiotic strain that colonizes the gut and modulates the intestinal microbiota and immune system to promote gastrointestinal health. Used for Maintenance of remission in ulcerative colitis, Traveler's diarrhea prevention, General gastrointestinal health and microbiota support.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}