{"id":"om-85-bv","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Mild fever"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Allergic reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OM-85 BV is composed of lysates from eight common respiratory pathogens (Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Klebsiella pneumoniae, Klebsiella ozaenae, Haemophilus influenzae, Branhamella catarrhalis, and Neisseria catarrhalis). It stimulates mucosal and systemic immunity through pattern recognition receptors, promoting the production of immunoglobulins and enhancing phagocytic activity. This broad immune activation reduces the incidence and severity of recurrent respiratory infections.","oneSentence":"OM-85 BV is a bacterial lysate immunostimulant that enhances innate and adaptive immune responses to prevent respiratory tract infections.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:58:11.731Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of recurrent respiratory tract infections"},{"name":"Recurrent sinusitis"},{"name":"Recurrent otitis media"},{"name":"Recurrent bronchitis"}]},"trialDetails":[{"nctId":"NCT05677763","phase":"PHASE4","title":"OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness","status":"ACTIVE_NOT_RECRUITING","sponsor":"OM Pharma SA","startDate":"2022-12-12","conditions":"Respiratory Tract Infections, Wheezing Lower Respiratory Illness","enrollment":525},{"nctId":"NCT05857930","phase":"PHASE2","title":"A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing","status":"ACTIVE_NOT_RECRUITING","sponsor":"OM Pharma SA","startDate":"2023-06-20","conditions":"Recurrent Wheezing, Wheezing Lower Respiratory Illness","enrollment":296},{"nctId":"NCT02148796","phase":"PHASE2","title":"Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness","status":"COMPLETED","sponsor":"University of Arizona","startDate":"2017-01-01","conditions":"Asthma, Wheezing","enrollment":822},{"nctId":"NCT05064631","phase":"PHASE2","title":"Bacterial Lysate In Preventing Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Queen Mary University of London","startDate":"2022-01-12","conditions":"Respiratory Tract Infections, Pediatric Respiratory Diseases, Wheezing","enrollment":173},{"nctId":"NCT07178002","phase":"PHASE4","title":"OM 85 to Prevent Respiratory Infections in Older At Risk Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fondazione Policlinico Universitario Campus Bio-Medico","startDate":"2024-12-19","conditions":"Respiratory Tract Infections (RTI)","enrollment":360},{"nctId":"NCT04129931","phase":"PHASE2","title":"PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2019-12-19","conditions":"Asthma","enrollment":395},{"nctId":"NCT06655272","phase":"PHASE4","title":"OM 85 to Prevent Respiratory Infections in Older At Risk Patients","status":"RECRUITING","sponsor":"Campus Bio-Medico University","startDate":"2025-02-01","conditions":"Respiratory Tract Infections (RTI)","enrollment":360},{"nctId":"NCT05063149","phase":"PHASE3","title":"Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.","status":"RECRUITING","sponsor":"Franciscus Gasthuis","startDate":"2022-01-18","conditions":"Wheezing, LRTI, Premature","enrollment":500},{"nctId":"NCT06553417","phase":"NA","title":"Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Dr. Soetomo General Hospital","startDate":"2023-06-01","conditions":"Dermatitis, Atopic","enrollment":60},{"nctId":"NCT06345014","phase":"PHASE4","title":"The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome","status":"RECRUITING","sponsor":"AJU Pharm Co., Ltd.","startDate":"2023-12-20","conditions":"Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome","enrollment":332},{"nctId":"NCT05222516","phase":"PHASE2","title":"Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD","status":"TERMINATED","sponsor":"OM Pharma SA","startDate":"2021-12-20","conditions":"Atopic Dermatitis","enrollment":63},{"nctId":"NCT04938908","phase":"PHASE2","title":"Probiotic in Dry Eye Syndromes","status":"COMPLETED","sponsor":"Shiraz University of Medical Sciences","startDate":"2021-07-01","conditions":"Dry Eye Syndrome","enrollment":40},{"nctId":"NCT04637425","phase":"PHASE3","title":"Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus","status":"COMPLETED","sponsor":"Medical University of Lublin","startDate":"2018-04-22","conditions":"Allergic Rhinitis","enrollment":70},{"nctId":"NCT04802616","phase":"PHASE3","title":"The Influence of Nonspecific Immunostimulation on Changes in the Concentration of iNKT Cells","status":"COMPLETED","sponsor":"Medical University of Lublin","startDate":"2021-03-22","conditions":"Allergic Rhinitis Due to Grass Pollen","enrollment":80},{"nctId":"NCT04496245","phase":"PHASE3","title":"Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85","status":"COMPLETED","sponsor":"The University of Queensland","startDate":"2020-08-24","conditions":"Respiratory Viral Infection, Covid19","enrollment":59},{"nctId":"NCT05270018","phase":"NA","title":"Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP","status":"UNKNOWN","sponsor":"Sheng Wang MD PhD","startDate":"2022-03-01","conditions":"Ventilators, Mechanical","enrollment":100},{"nctId":"NCT05044169","phase":"NA","title":"Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome","status":"UNKNOWN","sponsor":"Fang Deng","startDate":"2021-09","conditions":"Nephrotic Syndrome in Children","enrollment":83},{"nctId":"NCT04270552","phase":"PHASE3","title":"Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis","status":"COMPLETED","sponsor":"Medical University of Lublin","startDate":"2018-04-22","conditions":"Allergic Rhinitis","enrollment":76},{"nctId":"NCT01968421","phase":"PHASE4","title":"Prevention of OM-85 on Bronchiectasis Exacerbation","status":"COMPLETED","sponsor":"Chinese Academy of Medical Sciences","startDate":"2015-03-01","conditions":"Bronchiectasis With Acute Exacerbation","enrollment":196},{"nctId":"NCT03243565","phase":"PHASE4","title":"Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy","status":"UNKNOWN","sponsor":"Dr. Sami Ulus Children's Hospital","startDate":"2017-11-01","conditions":"Adenoid Hypertrophy, Adenoid Hyperplasia, Respiratory Tract Infections","enrollment":68},{"nctId":"NCT03047954","phase":"PHASE3","title":"Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis","status":"COMPLETED","sponsor":"Vifor Pharma","startDate":"2003-07","conditions":"Atopic Dermatitis","enrollment":179},{"nctId":"NCT02541331","phase":"PHASE3","title":"Efficacy Of Bacterial Lysate In Asthmatic Children","status":"COMPLETED","sponsor":"Lallemand Pharma AG","startDate":"2014-07","conditions":"Allergic Asthma","enrollment":150},{"nctId":"NCT02417649","phase":"PHASE4","title":"Advanced Immunological Approach in COPD Exacerbation","status":"COMPLETED","sponsor":"Lallemand Pharma AG","startDate":"2009-09","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":288},{"nctId":"NCT00733226","phase":"PHASE4","title":"Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing","status":"COMPLETED","sponsor":"Kecioren Education and Training Hospital","startDate":"2007-08","conditions":"Asthma","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":61,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Bronchovaxom","Bronchovaxom 3.5 mg placebo 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Used for Prevention of recurrent respiratory tract infections, Prophylaxis of acute exacerbations in chronic bronchitis and COPD.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}