Bifidobacterium longum BB536 for Ulcerative Colitis
Verdict: Published with Warning
Across 5 PubMed studies, the evidence for Bifidobacterium longum BB536 in Ulcerative Colitis 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
⚖️
Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.59
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
B · Published with Warning
Confidence
67%
Broadly consistent
Evidence level
E1
Cochrane high-quality SR/MA
▸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 = 0.592
- 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 > 0 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 (5)L2 · primary research & systematic reviews
Probiotics for induction of remission in ulcerative colitis
Finding: Across 14 RCTs (865 participants) probiotics may induce clinical remission vs placebo (RR 1.73, 95% CI 1.19-2.54, NNT=5), but certainty was LOW and no specific strain including Bifidobacterium was identified as superior.
View on PubMed Efficacy and safety of probiotics in IBD: An overview of systematic reviews and updated meta-analysis of randomized controlled trials
Finding: Pooling 45 RCTs, probiotics increased clinical remission in UC (OR 2.00, 95% CI 1.28-3.11), with multi-strain formulations driving benefit, but overall GRADE certainty was low.
View on PubMed Efficacy of probiotic treatment with Bifidobacterium longum 536 for induction of remission in active ulcerative colitis: A randomized, double-blinded, placebo-controlled multicenter trial
Finding: The only BB536-specific UC RCT (n=56) missed its PRIMARY endpoint: remission 63% (BB536) vs 52% (placebo), P=0.395 not significant; only secondary markers (UCDAI, endoscopic/Mayo subscore) improved within-group.
View on PubMed Bifidobacterium Longum: Protection against Inflammatory Bowel Disease
Finding: Narrative (non-systematic) review summarizing B. longum anti-inflammatory mechanisms in IBD; descriptive only, reports no pooled effect size and provides no quantitative efficacy estimate for ulcerative colitis.
View on PubMed Active hexose-correlated compound and Bifidobacterium longum BB536 exert symbiotic effects in experimental colitis
Finding: Preclinical RAT (TNBS) study, not human: BB536 combined with AHCC reduced colon weight/length ratio, myeloperoxidase and iNOS vs single agents, but no human clinical endpoint or effect size is reported.
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Supportive
GRN No. 877 — Bifidobacterium longum BB536. Intended use: ingredient in term infant formula at a level of 1 x 10^8 CFU per gram of product. FDA closure date: December 26, 2019. FDA letter: 'FDA has no questions' regarding the safety of Bifidobacterium longum BB536 when used as described in the notice. (Earlier GRN 268 covered use in conventional foods/beverages.) source↗
L4b EU EFSA
Cautious
Scientific Opinion on the substantiation of health claims related to Bifidobacterium longum BB536 and improvement of bowel regularity (ID 3004), normal resistance to cedar pollen allergens (ID 3006), and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 3005) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. Conclusion: Bifidobacterium longum BB536 does not improve… source↗
L4d TW TFDA / 衛福部
Neutral
健康食品查驗登記審查採雙軌制，第一軌為「個案審查」，第二軌為「規格標準審查」，通過審查的產品會給予健康食品(小綠人)標章，第一軌的產品上標有「衛部健食字第A00000號」，第二軌的產品標有「衛部健食規字第000000號」。目前健康食品可以宣稱的保健功效項目共有13項，包括調節血脂、胃腸功能改善、護肝、免疫調節、骨質保健、不易形成體脂肪、抗疲勞、輔助調整過敏體質、調節血糖、延緩衰老、牙齒保健、促進鐵吸收、輔助調節血壓。 source↗
L5b Mayo Clinic
Cautious
Evidence on probiotic supplements is mixed, and the American Gastroenterological Association does not recommend probiotic supplements for treating ulcerative colitis in most situations. However, they should be treated like medicine and discussed with your healthcare professional before use. source↗
L5c Cleveland Clinic
Cautious
Probiotics are probably not harmful, and if you take one and it makes you feel better then fantastic, keep taking it. They can be expensive, though. And there is definitely not evidence that it's going to make anything better long term. source↗
L5d Harvard Health
Cautious
Some studies suggest that certain bacterial strains, such as Bifidobacteria and Lactobacilli, are somewhat effective for ulcerative colitis. But these effects are modest compared to standard therapies, and probiotics have not shown enough benefit to be accepted in medical practice. source↗
L5e Specialty Society (condition-mapped)
Against
There is not sufficient evidence for routine use of probiotics, prebiotics, or other alternative therapies as primary induction therapy for patients with mildly to moderately active UC. source↗