Bifidobacterium longum BB536 for Immune Elderly
Verdict: Published with Warning
Across 5 PubMed studies, the evidence for Bifidobacterium longum BB536 in Immune Elderly grades Tier C — weak evidence. Effective, but with safety or population caveats.
C 🟠 C Weak Evidence Published with Warning
Why this grade7-layer evidence engine
This claim earns a Weak (C) grade because elderly strain-exact evidence is limited to small, manufacturer-linked trials. Namba 2010 (PMID 20460726, n=27, open-label) and Akatsu 2013 (PMID 23192454, n=45) in elderly or tube-fed elderly showed modest immune-marker changes but were not large, independent, or replicated.
The evidence_level was wrongly anchored on a large RCT (PMID 29065707, n=520) that enrolled Malaysian pre-school children aged 2–6, not older adults. EFSA has rejected BB536 immune claims. L11 independently grades B while published tier is C, reflecting surrogate endpoints only.
BB536 may modulate gut microbiota and some immune markers in small elderly cohorts, but there is no large, strain-exact RCT in seniors showing fewer infections or clinically meaningful immune benefit. Tier C with warning appropriately reflects weak, population-mismatched evidence.
⚖️
Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.55
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Published with Warning
Confidence
62%
Broadly consistent
Evidence level
E7
E5 wrongly anchored on PMID 29065707 (Malaysian pre-school children n=520, not elderly)
▸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 = 0.545
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 無高階證據可裁決
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 0 個 hard + 1 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (5)L2 · primary research & systematic reviews
Effects of Bifidobacterium longum BB536 administration on influenza infection, influenza vaccine antibody titer, and cell-mediated immunity in the elderly
Finding: The proportion of elderly subjects contracting influenza and the proportion with fever were both significantly lower in the BB536 group than placebo (P<0.05 reported as 'significantly lower'; no point estimate/CI given), with higher NK-cell and neutrophil bactericidal activity during the pre-administration period.
View on PubMed Bifidobacterium longum BB536 alleviated upper respiratory illnesses and modulated gut microbiota profiles in Malaysian pre-school children
Finding: BB536 had no significant effect on diarrhoea (primary) but significantly reduced duration of sore throat by 46% (P=0.018), with only marginal, non-significant reductions in fever (-27%, P=0.084), runny nose (-15%, P=0.087) and cough (-16%, P=0.087).
View on PubMed Clinical effects of probiotic Bifidobacterium longum BB536 on immune function and intestinal microbiota in elderly patients receiving enteral tube feeding
Finding: Surrogate immune markers only: NK-cell activity fell significantly in placebo but was preserved with BB536 (intergroup P<0.05 in the low-NK subgroup), serum IgA showed a non-significant upward trend (P=.085 wk4, P=.070 wk16), while influenza vaccine HI titers were NOT significantly affected.
View on PubMed Usefulness of Bifidobacterium longum BB536 in Elderly Individuals With Chronic Constipation: A Randomized Controlled Trial
Finding: On-target elderly RCT but for a constipation (not immune) endpoint: the primary endpoint was NOT met (between-group P=0.074); only secondary stool-frequency subscale improved (P=0.008); no immune outcome was measured.
View on PubMed The Potential Immunomodulatory Effect of Bifidobacterium longum subsp. longum BB536 on Healthy Adults through Plasmacytoid Dendritic Cell Activation in the Peripheral Blood
Finding: Mechanistic surrogate only, wrong population (healthy adults): live BB536 significantly increased CD86 expression on peripheral pDCs at week 4 vs placebo (P<0.05), and heat-killed BB536 raised IFN-gamma in vitro — but no clinical infection or elderly-immune endpoint was tested.
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↗
L5e Specialty Society (condition-mapped)
Cautious
Although the safety concerns noted here for S. boulardii may not be extrapolated to other probiotics such as lactobacilli, bifidobacteria, and others, use of any probiotic dietary supplement as a drug in diseased or immunocompromised populations requires specific evaluation of safety in that population. source↗