ID 904 - Lactobacillus reuteri ATCC 55730

PL: Lactobacillus reuteri ATCC 55730
EN: Lactobacillus reuteri ATCC 55730
Pdf: Lactobacillus reuteri ATCC 55730

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus reuteri ATCC 55730 (hereafter L. reuteri ATCC 55730). The strain L. reuteri ATCC 55730 is also known as Lactobacillus reuteri SD2112 (Connolly, 2004). The 16S rRNA sequence of the strain is deposited at Genbank (Accesion nº EU394679) and the strain has been characterised by both phenotypic and genotypic methods (Rosander et al., 2008). The sequencing of the genome of the strain is reported (Bath et al., 2005).
The Panel notes that a culture collection number from the American Type Culture Collection (ATCC) is provided.
The Panel considers that the food constituent, L. reuteri ATCC 55730, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

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, beneficially affect the intestinal flora, support a healthy intestinal flora, and balance intestinal flora”.
The numbers/proportions of bacterial groups that would constitute a “beneficial/healthy/balanced” 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, beneficially affect the intestinal flora, support a healthy intestinal flora, and balance intestinal flora”, are beneficial to human health.
The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

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

Thirty references were cited to substantiate the claimed effect. The references included human intervention studies, in vitro and animal studies, and reviews.
Three human studies demonstrated the presence of L. reuteri ATCC 55730 in faecal samples and gastric, duodenal and ileal mucosa after oral ingestion, and supporting survival and colonisation in the gastrointestinal tract (Valeur et al., 2004; Wolf et al., 1995; Wolf et al., 1998). Two studies investigated the safety aspects of the strain in both healthy males and HIV-infected subjects (Wolf et al., 1995; Wolf et al., 1998). The Panel notes that these references dealt with outcomes unrelated to the claimed effect.
In other studies the effect of the strain on clinical symptoms in different clinical conditions (acute diarrhoea, irritable bowel syndrome, infant colic, constipation, reduction of gingivitis and lowering infections rate) was evaluated (Tubelius et al., 2005; Niv et al., 2005; Ouweland etal., 2002; Ruiz- Palacios et al., 1996; Savino et al., 2005 and al., 2007; Shornikova et al,,1997a and 1997b; Weizman et al., 2003 and 2006; Guerrero et al., 1996; Krasse et al., 2006). The Panel notes that these studies do not address the claimed effect. Studies demonstrating reduced concentrations of salivary streptococci (Caglar et al., 2006; Nikawa et al., 2004) do not evaluate the effect of the bacterial strain on intestinal pathogens. The studies by Lionetti et al. (2005 and 2006) focused on reduction of side-effects of H. pylori treatment and reported on outcomes, which are unrelated to the claimed effect. The trial of Jakobsen et al. (2005, abstract of a poster) related to the effect of oral supplementation of Lactobacillus reuteri on the immunological composition of breast milk, which is also unrelated to the claimed effect.
In one study, dyspeptic Helicobacter pylori (H. pylori) positive patients were treated with omeprazole, L. reuteri ATCC 55730 (8x105 b.i.d.) or placebo (Saggioro, 2005, abstract of a poster). In another study, 40 asymptomatic healthy volunteers with a positive urea breath test for H. pylori were divided over 4 groups (Imase et al., 2005, abstract of a poster). Two of the groups received tablets containing L. reuteri ATCC 55730 (dose not known) for 4 weeks followed by placebo for 4 weeks or vice versa. The Panel notes that only the abstracts (of posters) were available and the full text of the publications were not retrievable. The abstracts did not provide sufficient information to allow a scientific evaluation.
In several in vitro and animal models antibacterial effects, immunomodulatory properties and the adhesion characteristics of L. reuteri ATCC 55730 were reviewed together with infection rates, morbidity and mortality caused by bacterial pathogens (Axelsson et al., 1989; Casas and Dobrogosz, 2000; Dobrogosz, 2005). The Panel considers that the evidence provided in the animal and in vitro studies does not predict the effect of L. reuteri ATCC 55730 consumption on the claimed effect in humans.
In weighing the evidence, the Panel took into account that the results of two human studies which related to Helicobacter pylori eradication were only available as poster abstracts, that the evidence in the animal and in vitro studies does not predict the effect of L. reuteri ATCC 55730 consumption on the claimed effect in humans, and that the remaining references dealt with outcomes unrelated to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus reuteri ATCC 55730 and decreasing potentially pathogenic intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

at least 1x108 cfu/day daily consumption