{"id":"bifidobacterium-infantis-35624","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Bloating"},{"rate":null,"effect":"Flatulence"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL4297912","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This strain of beneficial bacteria colonizes the intestinal tract and produces metabolites that strengthen the intestinal barrier, reduce pathogenic bacteria, and modulate local and systemic immune responses. It has been shown to reduce visceral pain, bloating, and other symptoms associated with irritable bowel syndrome through these microbiota-mediated mechanisms.","oneSentence":"Bifidobacterium infantis 35624 is a live probiotic bacterium that modulates the gut microbiota and intestinal immune function to reduce gastrointestinal symptoms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:13.844Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Irritable bowel syndrome (IBS)"}]},"trialDetails":[{"nctId":"NCT06421922","phase":"NA","title":"Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome","status":"COMPLETED","sponsor":"Gulhane Training and Research Hospital","startDate":"2019-06-01","conditions":"Irritable Bowel Syndrome-IBS","enrollment":60},{"nctId":"NCT00554099","phase":"PHASE2","title":"Asacol Acute Diverticulitis(DIVA)Study","status":"COMPLETED","sponsor":"Warner Chilcott","startDate":"2007-11","conditions":"Diverticulitis","enrollment":117},{"nctId":"NCT01099696","phase":"NA","title":"Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating","status":"COMPLETED","sponsor":"Procter and Gamble","startDate":"2010-04","conditions":"Abdominal Discomfort, Bloating","enrollment":302},{"nctId":"NCT00135031","phase":"PHASE3","title":"Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome","status":"COMPLETED","sponsor":"Procter and Gamble","startDate":"2004-01","conditions":"Irritable Bowel Syndrome","enrollment":362},{"nctId":"NCT00510978","phase":"PHASE2, PHASE3","title":"Probiotics in GastroIntestinal Disorders","status":"UNKNOWN","sponsor":"University College Cork","startDate":"2002-01","conditions":"Ulcerative Colitis, Crohn's Disease","enrollment":360}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"COORDINATION ABNORMAL"},{"count":1,"reaction":"DRUG INTERACTION"},{"count":1,"reaction":"FATIGUE"},{"count":1,"reaction":"FREQUENT BOWEL MOVEMENTS"},{"count":1,"reaction":"HEADACHE"},{"count":1,"reaction":"MUSCLE INJURY"},{"count":1,"reaction":"MUSCLE SPASMS"},{"count":1,"reaction":"PAIN"},{"count":1,"reaction":"POLLAKIURIA"},{"count":1,"reaction":"PRODUCT LABEL ISSUE"}],"_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":[],"phase":"phase_3","status":"active","brandName":"Bifidobacterium infantis 35624","genericName":"Bifidobacterium infantis 35624","companyName":"Procter and Gamble","companyId":"procter-and-gamble","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bifidobacterium infantis 35624 is a live probiotic bacterium that modulates the gut microbiota and intestinal immune function to reduce gastrointestinal symptoms. Used for Irritable bowel syndrome (IBS).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}