1242.pdf

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Scientific Opinion on the substantiation of health claims related to Lactobacillus plantarum 299v (DSM 9843) and decreasing potentially pathogenic intestinal microorganisms (ID 1084) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Lactobacillus plantarum 299v (DSM 9843)   health claims   intestinal flora   potentially pathogenic microorganisms  
ID:    1084  
Produkty: Lactobacillus plantarum 299v (DSM 9843)  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus plantarum 299v (DSM 9843) (hereafter L. plantarum 299v (DSM 9843)). The identification/characterisation of the strain L. plantarum 299v by both phenotypic (API 50CH) and genotypic methods is given (Johansson et al., 1993; Johansson et al., 1995; Johansson et al., 1998).
The Panel notes that a reference number from the DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen), DSM 9843, is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits.
The Panel considers that the food constituent, Lactobacillus plantarum 299v (DSM 9843), which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “gut health”. The Panel assumes that the target population is the general population.
“Gut health” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to the aspect of: “supporting a healthy intestinal flora”.
The numbers/proportions of bacterial groups that would constitute a “healthy intestinal flora” have not been established. Increasing the number of any groups of bacteria is not in itself considered as beneficial. The Panel considers that no evidence has been provided that the aspect of the claimed effect “supporting a healthy intestinal flora” is beneficial to human health.
The Panel considers that “supporting a healthy intestinal flora” in the context of decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych

Thirteen references were cited to substantiate the claimed effect.
The references provided include four randomised double-blind placebo-controlled studies in healthy volunteers. In these studies, the count of several bacteria was evaluated in stool (such as lactobacilli, bifidobacteria, Bacteroides spp., Clostridia spp., Enterococci spp.). In the first study (Goossens et al., 2003), 22 volunteers consumed L. plantarum 299v fermented oatmeal drink for 4 weeks. In the second study (Goossens et al., 2005), 29 subjects consumed 200 mL of a fermented oatmeal drink with L. plantarum 299v (109 cfu/mL) daily for two weeks. The third study (Önning et al. 2003) was randomised double-blinded parallel design study with 98 subjects who consumed daily 450 mL of a test drink containing rosehip-oats with the L. plantarum 299v (5x107 cfu/mL) or a placebo drink for 4 weeks. The forth study was controlled randomised double-blind study (Johansson et al., 1998), with 48 healthy adult volunteers who consumed for 21 days 400 mL daily of a rosehip drink containing oats and fermented with L. plantarum DSM 9843 (299v) (5x107 cfu/mL) or a pure rose-hip drink without the strain (placebo group). The Panel notes that in none of the studies a significant decrease of potentially pathogenic intestinal microorganisms was found compared to the control groups. Two studies investigated the effect of L. plantarum 299v in patients with irritable bowel syndrome, in one study the primary outcome measured was pain relief, which is unrelated to the claimed effect (Niedzielin et al., 2001), and in the other study no significant change in sulfite-reducing clostridia or Enterobacteriaceae were reported before or after the study (Nobaek et al., 2000).
The other references provided looked at adhesion properties of the bacterial strain onto the gut mucosa in critically ill patients needing intensive care and treated with broad-spectrum antibiotics (Klarin et al., 2005), recurrence of clinical symptoms (as main outcome) in patients with Clostridium difficile-diarrhoea (Wullt et al., 2003), and the influence of the strain on the concentrations of specific faecal organic acids also in patients with recurrent Clostridium difficile-diarrhoea treated with metronidazole (Wullt et al., 2007). The Panel notes that these references provided no scientific data that could be used to substantiate the claimed effect on decreasing potentially pathogenic intestinal microorganisms.
The remaining references related to a pilot study (Sallerfors et al., unpublished) with high doses of L. plantarum DSM 9873 in patients receiving autologous stem cell transplantation, a report on food products with L. plantarum 299v developed for children, and a review on gut health and diet. The Panel notes that these references cited provided no scientific data that could be used to substantiate the claimed effect.
Overall the Panel notes that none of the references provided evidence for a relationship between the consumption of L. plantarum 299v (DSM 9843) and decreasing potentially pathogenic intestinal microorganisms.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299v (DSM 9843) and decreasing potentially pathogenic intestinal microorganisms.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent, Lactobacillus plantarum 299v (DSM 9843), which is the subject of the health claim is sufficiently characterised.
The claimed effect is “gut health”. The target population is assumed to be the general population. Decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.
A cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299v (DSM 9843) and decreasing potentially pathogenic intestinal microorganisms.