2029.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus LB21 NCIMB 40564 and contribution to maintaining individual intestinal microbiota in subjects receiving antibiotic treatment (ID 1061) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Lactobacillus rhamnosus LB21 NCIMB 40564   antibiotics   health claims   microbiota  
ID:    1061  
Produkty: Lactobacillus rhamnosus LB21 NCIMB 40564  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus rhamnosus LB21 NCIMB 40564.
Reference to the identification and characterisation of the strain by different genotypic and phenotypic methods was found in the references provided and in the literature (Grahn Hakansson and Ekbeck, 2007; Vancanneyt et al., 2006). A culture collection number from the National Collection of Industrial and Marine Bacteria (UK), NCIMB 40564, is indicated and a culture deposited in the BCCM/LMG under number 23667 was also found.
The Panel considers that the food constituent, Lactobacillus rhamnosus LB21 NCIMB 40564, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “digestive system, immune system”. The Panel assumes that the target population is subjects receiving antibiotic treatment.
In the context of the proposed wording and the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of intestinal microbiota in subjects receiving antibiotic treatment. Disturbance of intestinal microbiota may be associated with adverse effects, for example gastro-intestinal infections.
The Panel considers that contribution to maintaining individual intestinal microbiota in subjects receiving antibiotic treatment might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowej flory bakteryjnej jelit u osób przyjmujących antybiotyki

Eleven references were provided in relation to this claim. These included a paper on the characterisation of Lactobacillus rhamnosus strains, a review paper on the current status of “probiotic” studies in human subjects, a paper addressing spray treatment with alpha-streptococci in children with secretory otitis, a study investigating the inhibition capacity of naturally occurring oral
lactobacilli against mutans streptococci in vitro, a study on the prophylactic effect of “probiotics” against cholangitis in children who underwent portoenterostomy owing to biliary atresia, studies addressing the effect of preparations combining several strains on constipation in patients with dementia (Lactobacillus rhamnosus LB21 and Lactococcus), and on the prevention of diarrhoea associated with antibiotics (yoghurt drink containing Lactobacillus casei DN-114001, Streptococcus thermophilus and Lactobacillus bulgaricus), a meta-analysis on the efficacy of “probiotics” in the prevention of acute diarrhoea, and an in vitro study which investigated the effect of Lactobacillus rhamnosus LB21 NCIMB 40564 on T-lymphocytes and production of cytokines by T-cells. The Panel notes that these references were either not related to Lactobacillus rhamnosus LB21 NCIMB 40564, were related to combinations of several strains, or did not address outcomes related to a claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim on Lactobacillus rhamnosus LB21 NCIMB 40564 alone.
Two human intervention studies were provided in the consolidated list.
The study by Larsson and Andersson (1996) investigated the effect of Lactobacillus rhamnosus LB21 on preventing antibiotic associated diarrhoea. Thirty-one healthy volunteers were given phenoxymethylpenicillin (500 mg t.i.d for 10 days). The volunteers were randomly assigned to receive Lactobacillus rhamnosus LB21 (1011 CFU/mL in 5 mL skimmed milk t.i.d for 15 days, n=16) or placebo group (5 mL of skimmed milk t.i.d for 15 days, n=13) during the antibiotic treatment. The outcome measures were the survival of Lactobacillus rhamnosus LB21 during antibiotic (phenoxymethylpenicillin) treatment, and the impact of the bacterium on number of stools, consistency of stools, abdominal pain and flatulence during antibiotic administration. The Panel notes the small sample size of the study, that no power calculation was indicated, and that data on individuals' gut microbiota profiles before and after/during antibiotic intake were not provided. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The study by Larsson et al. (Larsson et al., manuscript, no year given) investigated the survival of Lactobacillus rhamnosus LB21 during antibiotic (phenoxymethylpenicillin) treatment, and the impact of the bacterium on number of stools, consistency of stools, abdominal pain and flatulence during antibiotic administration in 27 subjects. Subjects were randomly assigned into two groups taking either Lactobacillus rhamnosus LB21 (1011 CFU/mL in 5 mL skimmed milk, twice daily, n=16) or placebo (5 mL skimmed milk, n=11) during the antibiotic treatment (10 days) and five days after the antibiotic treatment had stopped. The Panel notes the small sample size of the study, that no power calculation was presented, and that data on individuals' gut microbiota profiles before and after/during antibiotic intake were not provided. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus rhamnosus LB21 NCIMB 40564 and contribution to maintaining individual intestinal microbiota in subjects receiving antibiotic treatment.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, Lactobacillus rhamnosus LB21 NCIMB 40564, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “digestive system, immune system”. The target population is assumed to be subjects receiving antibiotic treatment. In the context of the proposed wordings and the clarifications provided by Member States, it is assumed that the claimed effect refers to the maintenance of intestinal microbiota in subjects receiving antibiotic treatment. Contribution
to maintaining individual intestinal microbiota in subjects receiving antibiotic treatment might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of Lactobacillus rhamnosus LB21 NCIMB 40564 and contribution to maintaining individual intestinal microbiota in subjects receiving antibiotic treatment.