Lactobacillus casei Shirota (LcS) for Helicobacter Pylori
Verdict: Published with Warning
Across 6 PubMed studies, the evidence for Lactobacillus casei Shirota (LcS) in Helicobacter Pylori grades Tier B — preliminary evidence. Effective, but with safety or population caveats.
B 🟡 B Preliminary Evidence Published with Warning
Why this grade7-layer evidence engine
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Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.61
D
C
B
A
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← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
B · Published with Warning
Confidence
74%
Broadly consistent
Evidence level
E2
Multiple high-quality MAs (≥2 independent, consistent)
▸View the full decision path (audit trail)
- compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.613
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高品質 SR/MA 顯示 positive (2 篇 > 1 negative)
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (6)L2 · primary research & systematic reviews
The effects of probiotics supplementation on Helicobacter pylori standard treatment: an umbrella review of systematic reviews with meta-analyses
Finding: Pooled (mixed/generic probiotic strains) probiotics improved eradication (RR 1.10, 95% CI 1.06-1.14) and reduced total side effects (RR 0.54, 95% CI 0.42-0.70), but overall evidence quality was rated critically low and Bifidobacterium spp.—not L. casei Shirota—showed the highest eradication potential.
View on PubMed Efficacy and safety of probiotics in eradicating Helicobacter pylori: A network meta-analysis
Finding: Across 40 RCTs (8,924 patients), adding probiotics raised eradication (RR 1.140, 95% CI 1.101-1.180, P<0.001) and lowered side effects (RR 0.470, 95% CI 0.391-0.565, P<0.001), but the analysis pooled generic probiotics and did not isolate Lactobacillus casei Shirota.
View on PubMed Efficacy of Lactobacillus-supplemented triple therapy for H. pylori eradication: A meta-analysis of randomized controlled trials
Finding: Across 11 RCTs (972 patients) Lactobacillus supplementation improved eradication overall (RR 1.16, 95% CI 1.08-1.25, P<0.0001), and the L. casei subgroup showed RR 1.33 (95% CI 1.10-1.62, P=0.004); however the L. casei trials used strains such as DN-114 001, not specifically the Shirota strain.
View on PubMed Eradication of Helicobacter pylori: triple treatment scheme plus Lactobacillus vs. triple treatment alone
Finding: Adding Lactobacillus casei strain Shirota to standard triple therapy raised eradication to 94% (29/31) versus 76% (25/33) with triple therapy alone (P<0.05), but the trial was small and open-label with no placebo control.
View on PubMed Effect of frequent consumption of a Lactobacillus casei-containing milk drink in Helicobacter pylori-colonized subjects
Finding: Urease activity fell in 9/14 (64%) L. casei recipients versus 2/6 (33%) untreated controls, a non-significant trend (P=0.22) on a surrogate marker, and L. casei Shirota did not eradicate H. pylori in any subject.
View on PubMed In vitro and in vivo inhibition of Helicobacter pylori by Lactobacillus casei strain Shirota
Finding: In 75 mice, L. casei Shirota significantly reduced H. pylori colonization and chronic/active gastric inflammation versus controls at 2-9 months (P<0.05), but this is a preclinical in vitro + animal study and does not establish human efficacy.
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Supportive
GRN No. 429 — Lactobacillus casei strain Shirota. Intended Use: As an ingredient in fermented dairy products at a maximum level of 4x10^8 colony forming units per milliliter. FDA Response: has no questions. Notifier: Yakult Honsha Co., Ltd. (Tokyo, Japan). Filed April 10, 2012; closed December 10, 2012. source↗
L4b EU EFSA
Against
The Panel concluded that a cause and effect relationship has not been established between the consumption of Lactobacillus casei Shirota and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. The Panel considered that there was no human study demonstrating an effect of Lactobacillus casei Shirota consumption on upper respiratory tract infections… source↗
L4c UK NHS
Cautious
Probiotics are generally classed as food rather than medicine, which means they don't go through the rigorous testing medicines do. ... There's some evidence that probiotics may be helpful in some cases, such as helping to ease some symptoms of irritable bowel syndrome (IBS). ... If you have an existing health condition or a weakened immune system, you should talk to a doctor before taking any … source↗
L4d TW TFDA / 衛福部
Supportive
養樂多活菌發酵乳 衛署健食字第A00032號 胃腸功能改善；養樂多300LIGHT活菌發酵乳 衛署健食字第A00128號 免疫調節、輔助調整過敏體質、胃腸功能改善；養樂多300活菌發酵乳 衛署健食字第A00178號 胃腸功能改善 source↗
L4e WHO
Neutral
Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. The 2002 FAO/WHO Working Group Guidelines for the Evaluation of Probiotics in Food require strain-level identification (genus, species, strain), in vitro testing (acid/bile tolerance), safety assessment (antibiotic resistance, metabolic activities, no transferable resistance), and… source↗
L5a NIH Office of Dietary Supplements
Neutral
With a total listing of over 500 scientific studies...it is fair to say that the L. casei strain Shirota is the most researched probiotic strain in the world. Classified as Lacticaseibacillus paracasei Shirota since April 2020. source↗
L5e Specialty Society (condition-mapped)
Cautious
There is insufficient evidence to suggest that the use of probiotic therapy improves the efficacy or tolerability of H. pylori eradication therapy. source↗