2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych

The claimed effect is “intestinal flora”. The Panel assumes that the target population is the general population.
“Intestinal flora” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “probiotic, and balances your healthy intestinal flora”.
The numbers/proportions of bacterial groups that would constitute a “balanced/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 aspects of the claimed effect, “probiotic” and “balances your healthy intestinal flora”, are beneficial to human health.
The Panel considers that “balances your healthy intestinal flora” in the context of decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

2.2. Poprawa pasażu jelitowego

The claimed effect is “intestinal transit”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to “improves your intestinal transit”.
The Panel considers that improvement of intestinal transit within the normal range might be beneficial to human health.

3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych

In a human intervention study (Olivares et al., 2006a), the effect of administration of the strains L. coryniformis CECT5711 and L. gasseri CECT5714 on short chain fatty acids (SCFA) faecal concentration and selected parameters of immune response was measured. Additionally, an impact on faecal bacteria counts was assessed. The study was a randomised, double-blind, placebo-controlled study in 30 adult volunteers (aged 23 – 43 years, 15 females). After a 2-week period of restricted diet without any fermented foods a combination of the strains L. coryniformis CECT5711 and L. gasseri CECT5714 vs. standard yogurt (containing 108 Streptococcus thermophilus) was administered during the next 2 weeks. A significant increase in lactobacilli counts was found in faecal cultures. The Panel notes that the effect of the combination of the strains on potentially pathogenic intestinal microorganisms was not measured in this study.
In a randomised, double-blind, placebo-controlled study in 30 healthy adults (aged 23–43 years, 15 females) investigated the oral administration of L. gasseri CECT5714 and L. coryniformis CECT5711 at a concentration of 2x109 cfu/day for each of the strains under investigation in a dairy product which also contained 108 Streptococcus thermophilus (Olivares et al., 2006c). The consumption of the evaluated strains led to a significant increase in the number of faecal lactic acid bacteria (from 6.97 ± 0.158 to 7.59 ± 0.213 cfu/g of faeces). The Panel notes that the effect of the combination of the strains on potentially pathogenic intestinal microorganisms was not measured in this study.
Lara-Villoslada et al. (2007a) evaluated the effects of consumption of the strains L. coryniformis CECT5711 and L. gasseri CECT5714 in 30 children aged between 3 and 12 years. It was conducted as a non-randomised, non-placebo controlled, 3 week sequential administration study of 200 mL of a normal yoghurt containing L. bulgaricus and S. thermophilus followed by administration of 80 mL of the yoghurt with L. bulgaricus substituted by the strains under investigation. Concentration of L. coryniformis CECT5711 was 1.8 x 107 cfu/g and L. gasseri CECT5716 was 2 x 106 cfu/g. An increase in faecal lactobacilli counts was shown at the end of the intervention (from 7.76 ± 0.15 to 8.05 ± 0.14 cfu/g of faeces (P < 0.05). No statistically significant differences were found in counts of other measured microorganisms (e.g. Bacteroides, Clostridia, Enterococci). The Panel notes that in this study no significant decrease of potentially pathogenic intestinal microorganisms was found compared to the control groups.
Other references submitted in the list are related to in vitro characteristics of both strains of bacteria, their properties (Martin et al., 2003, Martin et al., 2005a; Martin et al., 2005b; Olivares et al., 2005b), and safety aspects (Lara-Villoslada et al., 2007c) or are review papers (Guarner and Schaafsma, 1998; Lara-Villoslada et al., 2007b; Saavedra et al., 2001). The Panel notes that these references do not
assess the effect of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 consumption and decreasing potentially pathogenic intestinal microorganisms, and considers that these references did not provide scientific data that could be used to substantiate the claimed effect.
Overall, the human intervention studies cited did not show an effect of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 consumption and decreasing the potentially pathogenic intestinal microorganisms, and the other references did not provide scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711” and decreasing potentially pathogenic intestinal microorganisms.

3.2. Poprawa pasażu jelitowego

One randomised, double-blind, placebo-controlled study (Olivares et al., 2006c) in 30 healthy adults (aged 23–43 years, 15 females), investigated the oral administration of L. gasseri CECT5714 and L. coryniformis CECT5711 at a concentration of 2x109 cfu/day for each of the strains under investigation in a dairy product which also contained 108 Streptococcus thermophilus. The analysis included faecal cultures of the administered strains, genomic analysis, measurement of short chain fatty acids and water content of faeces. Bowel habits were evaluated with a questionnaire. Individuals who received the strains under investigation reported an increase in a stool volume score and in the number of stools/week at the end of the 4-week treatment period. Volunteers in both treatment arms reported a positive effect on the frequency of bowel movements which was significantly increased in the experimental group. The presence of both strains was transient and returned to basal levels 2 weeks after cessation of administration. The assessment of the frequency of bowel movements is questionnaire-based and showed a difference in the number of stools/week between the intervention group (8.0/week) and the control group (7.3/week). Participants in the experimental group reported a positive effect under the questionnaire item “bowel habit” compared to the control group. The Panel notes the weaknesses of the study which include the small sample size, short duration period, and lack of a validated questionnaire to assess the measured outcome.
Other references submitted in the list are related to in vitro characteristics of both strains of bacteria, their properties (Martin et al., 2003, Martin et al., 2005a; Martin et al., 2005b; Olivares et al., 2005b), and safety aspects (Lara-Villoslada et al., 2007c) or are review papers (Guarner and Schaafsma, 1998; Lara-Villoslada et al., 2007b; Saavedra et al., 2001). The Panel notes that these references do not assess the effect of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 consumption on the improvement of intestinal transit.
Overall, the Panel notes the weaknesses of the intervention study in healthy adults and that the other references cited provided no scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711” and improvement of intestinal transit within the normal range.