Bifidobacterium longum BB536 for C Difficile Infection
Verdict: Insufficient Evidence
Across 6 PubMed studies, the evidence for Bifidobacterium longum BB536 in C Difficile Infection grades Tier U — unverified / insufficient. Research is still too limited to draw a firm conclusion.
U ⚫ U Unverified Insufficient Evidence
Why this grade7-layer evidence engine
⚖️
Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.40
D
C
B
A
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← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
U · Insufficient Evidence
Confidence
71%
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 = 0.4
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高階證據未達主導 (1 positive vs 1 negative)，由 raw_score 決定
- 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
Probiotics for the prevention of Clostridioides difficile-associated diarrhea in adults and children
Finding: Across 47 trials probiotics (as a class) reduced CDAD incidence (RR 0.50, 95% CI 0.38-0.64; 1.6% vs 3.2%, NNT 65), but on low-certainty evidence and with no data isolating Bifidobacterium longum BB536.
View on PubMed A Multi-Hospital Comparative Study on the Efficacy of Probiotics Versus Placebo in Preventing Antibiotic-Associated Diarrhea in Adult Patients
Finding: A combined Lactobacillus rhamnosus GG + Bifidobacterium longum BB536 product reduced overall AAD (18.2% vs 31.2%, p=0.01) but the trial did NOT measure C. difficile infection as a distinct outcome, so it cannot confirm BB536 efficacy against CDI.
View on PubMed Lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea and Clostridium difficile diarrhoea in older inpatients (PLACIDE): a randomised, double-blind, placebo-controlled, multicentre trial
Finding: The largest RCT of a multistrain lactobacilli+bifidobacteria preparation found NO benefit for C. difficile diarrhoea (0.8% vs 1.2%; RR 0.71, 95% CI 0.34-1.47, p=0.35) nor for AAD.
View on PubMed Evaluation of probiotics efficiency for the prevention of Clostridioides difficile infection in hospitalized patients: a meta-analysis
Finding: Pooling four studies, probiotics (class-level) showed NO significant effect on CDI (OR 0.99, 95% CI 0.56-1.7, non-significant) with high heterogeneity; no BB536-specific data.
View on PubMed Which probiotic has the best effect on preventing Clostridium difficile-associated diarrhea? A systematic review and network meta-analysis
Finding: Across 10 RCTs Lactobacillus casei ranked best for CDAD prevention (OR 0.19, 95% CrI 0.06-0.63); Lactobacilli outperformed Bifidobacterium-based preparations, and Bifidobacterium longum BB536 was not separately evaluated.
View on PubMed Add-on interventions for the prevention of recurrent Clostridioides difficile infection: A systematic review and network meta-analysis
Finding: Across 15 trials probiotics were NOT superior to placebo for preventing recurrent CDI (evidence rated uncertain); effective add-ons were instead oligofructose (OR 0.17, 0.07-0.46), bezlotoxumab (OR 0.53, 0.42-0.68) and rifaximin (OR 0.47, 0.24-0.93).
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↗
L5c Cleveland Clinic
Cautious
Regardless, probiotics are safe and inexpensive. They may help prevent C. diff or reduce symptoms. I recommend probiotics for people taking antibiotics for more than seven days if they are worried about C. diff. But scientists don't yet know which probiotic species, strengths and ratios are effective. source↗
L5d Harvard Health
Cautious
Probiotics haven't been found to prevent C. diff or its recurrence. source↗
L5e Specialty Society (condition-mapped)
Against
We recommend against probiotics for the prevention of CDI in patients being treated with antibiotics (primary prevention) (conditional recommendation, moderate quality of evidence). We recommend against probiotics for the prevention of CDI recurrence (secondary prevention) (strong recommendation, very low quality of evidence). source↗