Safety assessment of probiotics for human use

Figures & data

Figure 1 A general scheme for the assessment of suitability for QPS status of microorganisms.196 Reprinted with permission.

Table 1 Effects of probiotic treatment in 7 randomized controlled trials in surgical patients with a high risk of post operative bacterial infections

	Category	Length of therapy (days)	Treatment	n	Control group	n	Infection rate (probiotic vs. control)
Post-operative treatment
203	Major abdominal surgery (liver gastric, pancreas colon)	5 post	10^9 L. plantarum 299 + oat fiber	30	109 heat killed L. plantarum 299 + oat fiber	30	10% vs. 10% (n.s.)
134	Liver transplantation	12 post	10^9 L. plantarum 299 + oat fiber	31	10^9 heat killed L. plantarum 299 + oat fiber	32	13% vs. 34% (n.s.)
204	Liver transplantation	14 post	Synbiotic 2000 (10^10 of 4 different LAB and 4 fibers)	33	Fibers only	33	3% vs. 48% (p = <0.0001)
205	Hepatectomy	14 post	10^8 B. breve, 10^8 L. casei + enteral feeding	21	Enteral feeding	23	19% vs. 52% (p = 0.03)
Peri-operative treatment
206	PPPD	1 pre 8 post	Synbiotic 2000 (10^10 of 4 different LAB and 4 fibers)	40	Fibers only	40	12.5% vs. 40% (p = 0.01)
207	PPPD	3–15 pre 10 post	E. faecalis, C. butyricum, Bacillus mesentericus	30	No treatment	34	23% vs. 53% (p = 0.02)
38	Hepatectomy	14 pre 14 post	10^10 B. breve, 10^10 L. casei (perioperatively)	41	10^10 B. breve, 10^10 L. casei (post operatively only)	40	12.1% vs. 30% (p = 0.049)

PPPD, pylorus-preserving pancreaticoduodenectomy; post, post-operatively; pre, pre-operatively; L, Lactobacillus; B, Bifidobacterium; E, Enterococcus; C, Clostridium. p values were calculated using Fisher's exact test.

On a generic approach to the safety assessment of micro-organisms used in feed/food and feed/food production 2003; 2009 http://ec.europa.eu/food/fs/sc/scf/out178_en.pdf

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