{
  "slug": "probiotics",
  "name": "Probiotics (live beneficial microorganisms)",
  "alternate_names": [
    "Probiotic",
    "Live cultures",
    "Lactobacillus / Bifidobacterium spp.",
    "Saccharomyces boulardii",
    "Beneficial gut bacteria"
  ],
  "mechanism": [
    "Competitive exclusion of pathogens and modulation of gut microbiota composition (research context)",
    "Strengthening of intestinal epithelial barrier and tight-junction function (mechanistic)",
    "Production of short-chain fatty acids (SCFAs · e.g. butyrate) from fermentation (research context)",
    "Immune modulation via gut-associated lymphoid tissue and cytokine signaling (research context)",
    "Lactase activity of live yogurt cultures aiding lactose digestion (EFSA-authorized mechanism for L. bulgaricus + S. thermophilus)"
  ],
  "target": [
    "Gut microbiota / microbiome composition",
    "Intestinal epithelial barrier",
    "Gut-associated immune system (GALT)",
    "Lactose digestion (yogurt cultures)"
  ],
  "use_case": [
    "digestive / gut health support (research-context; strain-specific)",
    "lactose-digestion support from live yogurt cultures (EFSA-authorized claim · strain-specific)",
    "antibiotic-associated and traveler's diarrhea reduction (research-context · specific strains)",
    "immune / gut-barrier support (research-context · strain-dependent)"
  ],
  "body_system": [
    "GUT",
    "IMMUNE"
  ],
  "evidence_tier": "B",
  "evidence_anchor_pmid_count": 3,
  "dosage_range": "Educational reference, not a dosing recommendation. Trials commonly use 1-50 billion CFU/day; effects are strain- and indication-specific (no single 'probiotic' dose). The EFSA-authorized live-yogurt-culture lactose claim requires >=10^8 CFU/g of L. delbrueckii subsp. bulgaricus + S. thermophilus.",
  "safety_notes": "Generally well tolerated in healthy adults; transient bloating/gas may occur at start. Caution and medical guidance for immunocompromised, critically ill, central-venous-catheter, or short-bowel patients (rare risk of bacteremia/fungemia). Effects are strain-specific — evidence for one strain does not transfer to another. Quality/viability varies by product. No adequate data for some strains in pregnancy/lactation. Educational, not medical advice — not a treatment for any disease.",
  "regulatory": {
    "fda": "Many probiotic strains hold self-affirmed or notified GRAS status and are lawfully sold as dietary supplements under DSHEA; structure/function claims only with mandatory disclaimer. NO generic FDA-authorized health claim for 'probiotics' (the 2026 yogurt qualified health claim is product/strain-specific). 'FDA approved' is prohibited.",
    "efsa": "One EFSA-authorized Reg 432/2012 claim covers live yogurt cultures (L. delbrueckii subsp. bulgaricus + S. thermophilus) improving lactose digestion at >=10^8 CFU/g. The generic term 'probiotic' is treated as an unauthorized health claim in the EU; supplements are otherwise lawful under Directive 2002/46/EC.",
    "anvisa": "Probiotic strains are permitted in dietary supplements (suplementos alimentares) under the ANVISA RDC 243/2018 framework and probiotics technical regulation, subject to the approved strain list and viability requirements; no generic IN 28/2018 Anexo V functional claim for the 'probiotics' category.",
    "cn": "Permitted: China maintains an NHC positive list of probiotic strains (~39) usable in common food; listed strains are lawful in food, and probiotic health foods can be registered with NMPA (Blue Hat). Strain must be on the approved inventory."
  },
  "regulatory_markets": [
    {
      "market": "US",
      "status": "DSHEA",
      "tier": "permitted"
    },
    {
      "market": "EU",
      "status": "2002/46/EC",
      "tier": "permitted"
    },
    {
      "market": "CN",
      "status": "Common Food",
      "tier": "permitted"
    },
    {
      "market": "BR",
      "status": "ANVISA",
      "tier": "permitted"
    }
  ],
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/probiotics/",
  "related_goal_slugs": [
    "gut-digestion",
    "inflammation-relief"
  ],
  "related_lifestyle_slugs": [
    "weight-management",
    "senior-60-plus"
  ],
  "last_evidence_review": "2026-06-22",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-22",
    "ip_axes_disclosed": {
      "public_axes": [
        "mechanism",
        "target",
        "use_case",
        "body_system",
        "evidence_tier",
        "dosage_range",
        "safety_notes",
        "regulatory",
        "authorized_claims"
      ],
      "ip_axes_not_exposed": [
        "proprietary_formula_ratios",
        "clinical_protocol_internals",
        "proprietary_research_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition and clinical-protocol internals are intentionally outside this public surface."
    }
  }
}