2.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces
gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.

2.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel notes that it is not possible to define the exact number of the different microbial groups which constitute a normal/healthy microbiota. Increasing the number of any groups of microorganisms, including lactobacilli, is not in itself considered to be a beneficial physiological effect.
The Panel assumes that the claimed effect refers to decreasing potentially pathogenic gastro- intestinal microorganisms. The Panel considers that decreasing potentially pathogenic gastro- intestinal microorganisms might be a beneficial physiological effect.

2.3. Poprawa trawienia laktozy (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel assumes that the claimed effect refers to improved lactose digestion, and that the target population is individuals with lactose maldigestion. Lactose maldigestion is a common condition caused by reduced levels of intestinal lactase.
The Panel considers that improved lactose digestion is a beneficial physiological effect for individuals with lactose maldigestion

2.4. Zwiększenie produkcji interleukiny 10 (IL-10) (ID 2973)

The claimed effect which is proposed for further assessment is: “Supports your natural (immune) defence system by increasing the IL-10 production in peripheral blood mononuclear cells (PBMC); Necessary to maintain the natural defences/helps to maintain a balanced immune system (increasing the IL-10 production)”. The proposed target population is the general population.
The Panel notes that the claimed effect “supports your natural (immune) defence system /necessary to maintain the natural defences/helps to maintain a balanced immune system” is not sufficiently defined, and assumes that the claimed effect relates to increasing IL-10 production by peripheral blood mononuclear cells. The Panel notes that increasing IL-10 production by peripheral blood mononuclear cells is not a beneficial physiological effect per se, but needs to be linked to a beneficial physiological or clinical outcome.
The references provided in relation to the claim were related to the methodology for bacterial strain identification, in vitro studies on the immunomodulatory properties of the combination of the strains (i.e. phenotype of the lymphocytic subpopulations, and cytokine production such as IL-10, IL-12, INFγ; (Castellazzi et al., 2007; Castellazzi, 2007a, unpublished)), and a patent (Dondi and Malfa,
2007) which reported on the use of the lactic bacteria that are the subject of the claim for the preparation of a composition suitable for modulating the immune system, and also on the in vitro effects of the strains on lymphocytes (lymphocyte proliferation, phenotype of the lymphocytic subpopulations, and cytokine production), but without providing primary data. Two references reported on the same human intervention study (Castellazzi, 2007a, unpublished; Valsecchi et al., 2008), which was an open-label, single arm (non-placebo controlled) study which investigated the effects of a combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 on symptoms of allergy (atopic dermatitis, rhino-conjunctivitis, urticaria, contact dermatitis, oral allergy syndrome and food allergies), and on immunological parameters (e.g. lymphocyte population, natural killer cell activity and cytokine production), in 20 children with atopic disorders. The Panel notes that this study was a single-arm study with no control group, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel considers that the evidence provided does not establish that increasing IL-10 production by peripheral blood mononuclear cells is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and a beneficial physiological effect related to an increase in IL-10 production.

3.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); patents for the use of two Lactobacillus strains (L. gasseri P-17632 and/or L. salivarius CNCM I-1794) other than the combination that is the subject of the claim against Candida albicans (Dondi, 2004, 2007); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains that is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and reduction of gastro-intestinal discomfort.

3.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains that is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two patents for the use of L. gasseri P-17632 and/or L. salivarius CNCM I-1794 against Candida albicans (Dondi, 2004, 2007) were also provided. The Panel notes that only one of the strains mentioned in the patents is part of the combination of strains that is the subject of the claim, and that no primary data were provided that could be used for the substantiation of the claim. The Panel considers that no conclusions can be drawn from these patents for the scientific substantiation of the claim.
The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and decreasing potentially pathogenic gastro-intestinal microorganisms.

3.3. Poprawa trawienia laktozy (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); patents for the use against Candida albicans of two Lactobacillus strains (Lactobacillus gasseri P-17632 and/or L. salivarius CNCM I-1794) other than the combination that is the subject of the claim (Dondi, 2004, 2007); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains hat is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and improved lactose digestion.