{"id":"1133933b-f81c-5d7f-8251-7a18324cb977","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-premote-gi","predicate":"increases","statement":"Gastrointestinal side effects were more frequent with berberine in PREMOTE.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"95d6af9d-0fb2-57f3-8159-f6727da0937b","mechanism_event_label":"Clinical benefits and tolerability are recorded separately.","subject":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"object":{"id":"17ab2004-d1be-5cd5-8c13-bbd31a6f730c","slug":"gastrointestinal-adverse-events","display_name":"Gastrointestinal adverse events","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"95d6af9d-0fb2-57f3-8159-f6727da0937b","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-premote-gi-event","event_type":"observed_intervention","label":"Clinical benefits and tolerability are recorded separately.","description":"Gastrointestinal side effects were more frequent with berberine in PREMOTE.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"17ab2004-d1be-5cd5-8c13-bbd31a6f730c","slug":"gastrointestinal-adverse-events","display_name":"Gastrointestinal adverse events","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/berberine-research/33024120.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"5dbbfd240d55ac62d2f48263f25e5543e47aa4a91d7711637fbacc543ce54bd9\", \"start_char\": 0, \"end_char\": 1283, \"text_sha256\": \"5dbbfd240d55ac62d2f48263f25e5543e47aa4a91d7711637fbacc543ce54bd9\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Multicenter randomized double-blind four-arm trial with metagenomics and microbial validation","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Twelve weeks of berberine, probiotics, both or placebo after one week of gentamycin pretreatment","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Antibiotic run-in and Chinese drug-naive population limit generalization. Microbial mediation is supported but not proof it explains every effect. Probiotic addition did not show a clear extra HbA1c reduction in the reported estimates.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Berberine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"409 newly diagnosed type 2 diabetes patients; separate bacterial experiments","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Clinical benefits and tolerability are recorded separately.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[berberine-p33024120] Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). (2020). https://pubmed.ncbi.nlm.nih.gov/33024120/ DOI: 10.1038/s41467-020-18414-8","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Glycemia, gut microbiome and bile-acid transformation","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"c69a7c24-771e-5b22-bd2a-9b1e52009594","evidence_kind":"source_excerpt","locator":"Lines 1169-1180","start_line":1169,"end_line":1180,"excerpt":"### berberine-premote-gi\nGastrointestinal side effects were more frequent with berberine in PREMOTE.\nCondition category: normal\nnutrient_topic: Berberine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Clinical benefits and tolerability are recorded separately.\norganism: 409 newly diagnosed type 2 diabetes patients; separate bacterial experiments\ntissue_or_cell_type: Glycemia, gut microbiome and bile-acid transformation\nexperimental_model: Multicenter randomized double-blind four-arm trial with metagenomics and microbial validation\nlimitations: Antibiotic run-in and Chinese drug-naive population limit generalization. Microbial mediation is supported but not proof it explains every effect. Probiotic addition did not show a clear extra HbA1c reduction in the reported estimates.\nexposure: Twelve weeks of berberine, probiotics, both or placebo after one week of gentamycin pretreatment\nevidence_span: {\"source_cache\": \"artifacts/berberine-research/33024120.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"5dbbfd240d55ac62d2f48263f25e5543e47aa4a91d7711637fbacc543ce54bd9\", \"start_char\": 0, \"end_char\": 1283, \"text_sha256\": \"5dbbfd240d55ac62d2f48263f25e5543e47aa4a91d7711637fbacc543ce54bd9\"}\n[berberine-p33024120] Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). (2020). https://pubmed.ncbi.nlm.nih.gov/33024120/ DOI: 10.1038/s41467-020-18414-8","model_system":"Multicenter randomized double-blind four-arm trial with metagenomics and microbial validation","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [berberine-p33024120] Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). (2020). https://pubmed.ncbi.nlm.nih.gov/33024120/ DOI: 10.1038/s41467-020-18414-8","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"9bb61e1d-e5cf-5b05-a9ca-409291f7a313","stable_key":"import-7484635e-cc8f-5cd6-a978-6dc5775a7db5","title":"Berberine: metabolism, nutrient connections and drug interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. 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