{"id":"e-coli-nissle","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Abdominal pain"},{"rate":"5-15%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Flatulence"}]},"_chembl":{"chemblId":"CHEMBL1909064","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"E. coli Nissle is a commensal bacterium that colonizes the gut and produces metabolites that influence the host's immune system and overall health. By modulating the gut microbiome, E. coli Nissle can help to prevent and treat various diseases.","oneSentence":"E. coli Nissle is a probiotic bacterium that modulates the gut microbiome to exert its therapeutic effects.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:26.178Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis"},{"name":"Irritable bowel syndrome"}]},"trialDetails":[{"nctId":"NCT05816577","phase":"PHASE1","title":"Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers","status":"COMPLETED","sponsor":"Max Nieuwdorp","startDate":"2023-09-18","conditions":"Diabetes","enrollment":20},{"nctId":"NCT06040515","phase":"","title":"Probiotic After Acute Colonic Diverticulitis","status":"UNKNOWN","sponsor":"Erasmo Spaziani","startDate":"2023-05-01","conditions":"Diverticulitis, Colonic, Therapy","enrollment":145},{"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":"NCT04969679","phase":"PHASE4","title":"Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.","status":"COMPLETED","sponsor":"Kangbuk Samsung Hospital","startDate":"2018-03-16","conditions":"Ulcerative Colitis","enrollment":134},{"nctId":"NCT04787276","phase":"NA","title":"Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy","status":"COMPLETED","sponsor":"Bogomolets National Medical University","startDate":"2017-01-10","conditions":"Hepatic Encephalopathy, Liver Cirrhosis, End Stage Liver DIsease","enrollment":42},{"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":"NCT02726295","phase":"PHASE4","title":"The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study","status":"COMPLETED","sponsor":"Keimyung University Dongsan Medical Center","startDate":"2016-09","conditions":"Constipation","enrollment":112},{"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":"NCT02953171","phase":"NA","title":"Probiotics in the Treatment of Irritable Bowel Syndrome","status":"UNKNOWN","sponsor":"University of Copenhagen","startDate":"2016-09","conditions":"Irritable Bowel Syndrome","enrollment":140},{"nctId":"NCT02276508","phase":"PHASE1","title":"Open Label Trial of Nissle 1917","status":"COMPLETED","sponsor":"Elizabeth Lucas","startDate":"2014-10","conditions":"Urinary Tract Infections","enrollment":20},{"nctId":"NCT01772615","phase":"PHASE4","title":"Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle","status":"COMPLETED","sponsor":"Hvidovre University Hospital","startDate":"2011-05","conditions":"Ulcerative Colitis","enrollment":100},{"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},{"nctId":"NCT01013259","phase":"PHASE2","title":"Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2009-02","conditions":"Rhinoconjunctivitis","enrollment":34}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ANAPHYLACTIC REACTION"},{"count":1,"reaction":"FLUSHING"}],"_approvalHistory":[],"publicationCount":386,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Mutaflor"],"phase":"phase_3","status":"active","brandName":"e.-coli-nissle","genericName":"e.-coli-nissle","companyName":"GWT-TUD GmbH","companyId":"gwt-tud-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"E. coli Nissle 1917, also known as Mutaflor Suspension, has been studied for its potential to treat various conditions, including Escherichia Coli Infections, Diabetes, Urinary Tract Infections in Children, Secondary Prevention, and Irritable Bowel Syndrome. The exact mechanism of E. coli Nissle 1917 is not specified in the provided information, but it has been used in clinical trials involving blood and stool samples.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}