{"id":"mbk-01","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal symptoms (abdominal discomfort, diarrhea, constipation)"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fever or systemic inflammatory response"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a live biotherapeutic product, MBK-01 likely contains selected bacterial strains designed to restore dysbiotic microbiota composition. By rebalancing the microbial ecosystem, it aims to enhance barrier function, reduce pathogenic bacterial overgrowth, and promote anti-inflammatory immune responses through microbial metabolite production and immune cell education.","oneSentence":"MBK-01 is a microbiome-based therapeutic that modulates the composition and function of the gut microbiota to restore immune homeostasis and reduce inflammation.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:20:21.188Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammatory bowel disease or related gastrointestinal inflammatory conditions (specific indication not publicly confirmed)"}]},"trialDetails":[{"nctId":"NCT06687382","phase":"PHASE2","title":"Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis","status":"RECRUITING","sponsor":"Mikrobiomik Healthcare Company S.L.","startDate":"2025-04-03","conditions":"Diverticulitis, Diverticulitis of Sigmoid","enrollment":81},{"nctId":"NCT05201079","phase":"PHASE3","title":"Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin","status":"COMPLETED","sponsor":"Mikrobiomik Healthcare Company S.L.","startDate":"2021-10-29","conditions":"Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection","enrollment":93},{"nctId":"NCT05622526","phase":"PHASE2","title":"Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer for the Treatment of Patients With Nonalcoholic Steatohepatitis","status":"UNKNOWN","sponsor":"Instituto de Investigación Marqués de Valdecilla","startDate":"2024-01-01","conditions":"Patients With Nonalcoholic Steatohepatitis","enrollment":96}],"_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":["Fecal microbiota transfer","Fecal Microbiota Transplantation","Intestinal Microbiota Transplantation"],"phase":"phase_3","status":"active","brandName":"MBK-01","genericName":"MBK-01","companyName":"Mikrobiomik Healthcare Company S.L.","companyId":"mikrobiomik-healthcare-company-s-l","modality":"Biologic","firstApprovalDate":"","aiSummary":"MBK-01 is a microbiome-based therapeutic that modulates the composition and function of the gut microbiota to restore immune homeostasis and reduce inflammation. Used for Inflammatory bowel disease or related gastrointestinal inflammatory conditions (specific indication not publicly confirmed).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}