{"id":"bacillus-subtilis","_fda":{"id":"40e5e7b1-80c8-b406-e063-6394a90ac7e2","set_id":"078a93ce-2f9b-f3ea-e063-6394a90a437c","openfda":{"unii":["8CF93KW41W"],"route":["ORAL"],"spl_id":["40e5e7b1-80c8-b406-e063-6394a90ac7e2"],"brand_name":["SYMBIO TILIS DROPS"],"spl_set_id":["078a93ce-2f9b-f3ea-e063-6394a90a437c"],"package_ndc":["69710-235-11"],"product_ndc":["69710-235"],"generic_name":["BACILLUS SUBTILIS"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BACILLUS SUBTILIS"],"manufacturer_name":["Symbiopathic"],"is_original_packager":[true]},"purpose":["PURPOSE: For internal indications according to traditional homeopathic practice."],"version":"3","warnings":["WARNINGS: Do not use if the tamper evident strip is broken or removed from the base of the cap."],"questions":["QUESTIONS: Call toll-free from US & CA +1-844-880-4881 or visit our website www.biological-health.com"],"ask_doctor":["ASK DOCTOR: Consult a physician if symptoms worsen or last for more than 7 days."],"effective_time":"20251011","active_ingredient":["ACTIVE INGREDIENTS: Bacillus subtilis 6X"],"inactive_ingredient":["INACTIVE INGREDIENTS: Purified water USP, sodium chloride"],"indications_and_usage":["INDICATIONS: This remedy is indicated for symptoms associated with skin and lung conditions, stomach and intestinal imbalance, rheumatism symptoms, skin allergies, and other internal conditions according to traditional homeopathic practice.*"],"spl_unclassified_section":["OTHER INFORMATION: Protect from light and heat. For professional distribution only. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."],"dosage_and_administration":["DIRECTIONS: Take 5 drops orally, three times per week."],"spl_product_data_elements":["SYMBIO TILIS DROPS Bacillus subtilis SODIUM CHLORIDE WATER BACILLUS SUBTILIS BACILLUS SUBTILIS"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding... If pregnant or breast feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN: KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or call a Poison Control Center right away."],"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY: Tilis"]},"safety":{"boxedWarnings":[]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Bacillus subtilis","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T07:07:01.805540+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bacillus Subtilis","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T07:07:09.494226+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:07:36.175631+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T07:07:08.122905+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Bacillus subtilis","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:07:08.449524+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:07:00.688915+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:07:28.839317+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:07:00.688948+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Protective antigen vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:07:09.494169+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068494/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:07:09.157577+00:00"}},"_dailymed":{"setId":"078a93ce-2f9b-f3ea-e063-6394a90a437c","title":"SYMBIO TILIS DROPS (BACILLUS SUBTILIS) LIQUID [SYMBIOPATHIC]"},"aiSummary":"Bacillus subtilis, marketed by DreamTec Research Limited, is positioned in the treatment of skin and lung conditions. The drug's key strength lies in its unique mechanism of action, which differentiates it from existing treatments. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","_scrapedAt":"2026-03-28T04:30:05.854Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bacillus_subtilis","title":"Bacillus subtilis","extract":"Bacillus subtilis, known also as the hay bacillus or grass bacillus, is a gram-positive, catalase-positive bacterium, found in soil and the gastrointestinal tract of ruminants, humans and marine sponges. Bacillus subtilis is motile and amylase positive. It forms biofilms through the formation of extracellular polymeric matrix containing sugars and proteins. As a member of the genus Bacillus, B. subtilis is rod-shaped, and can form a tough, protective endospore, allowing it to tolerate extreme environmental conditions. B. subtilis has historically been classified as an obligate aerobe, though evidence exists that it is a facultative anaerobe. B. subtilis is considered the best studied Gram-positive bacterium and a model organism to study bacterial chromosome replication and cell differentiation. It is one of the bacterial champions in secreted enzyme production and used on an industrial scale by biotechnology companies."},"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T07:07:36.175713+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"bacillus-subtilis-skin-and-lung-conditions","name":"Skin and Lung Conditions","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"bacillus-subtilis-stomach-and-intestinal-imbalan","name":"Stomach and Intestinal Imbalance","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"bacillus-subtilis-rheumatism-symptoms","name":"Rheumatism Symptoms","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"bacillus-subtilis-skin-allergies","name":"Skin Allergies","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"bacillus-subtilis-other-internal-conditions","name":"Other Internal Conditions","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT07426705","phase":"PHASE4","title":"Effect of Multispecies Probiotic Supplementation on the Efficacy of Rifaximin α Therapy in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Randomized Placebo-controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji","startDate":"2026-02-15","conditions":"Small Intestinal Bacterial Overgrowth Syndrome (SIBO), IBS","enrollment":100},{"nctId":"NCT07399717","phase":"NA","title":"Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia","status":"NOT_YET_RECRUITING","sponsor":"Anabio R&D","startDate":"2026-01-26","conditions":"Pneumonia, Pneumonia in Children","enrollment":330},{"nctId":"NCT07377942","phase":"NA","title":"To Evaluate the Effect of Bacillus Subtilis Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults.","status":"ENROLLING_BY_INVITATION","sponsor":"Bioagile Therapeutics Pvt. 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