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Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of defence against pathogenic gastrointestinal microorganisms pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Journal 2011;9(6):2167[19 pp.]. doi:10.2903/j.efsa.2011.2167
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen Acknowledgment The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion Possible conflict of interest One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Competent Authority of Finland Question number: EFSA-Q-2010-01028 Adopted: 13 May 2011 Published: 01 June 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Valio Ltd., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillus rhamnosus GG (LGG) and maintenance of defence against pathogenic gastrointestinal (GI) microorganisms. LGG is sufficiently characterised. The Panel considers that the health claim refers to the defence against GI pathogens in the general population without GI infections and does not include the treatment of GI infections. Maintenance of defence against pathogenic GI microorganisms is a beneficial physiological effect. Only one out of five human intervention studies showed an effect of LGG consumption on the development of GI infections, two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination and, in the absence of evidence for an effect of LGG consumption on the development of GI infections in the general population, studies on the treatment of GI infections, on diarrhoea during antibiotic use, or mechanistic studies, cannot be used as a source of data for the scientific substantiation of the health claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of LGG and maintenance of defence against pathogenic gastrointestinal microorganisms.

© European Food Safety Authority,2011

Summary

Following an application from Valio Ltd., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillus rhamnosus GG, ATCC 53103, and maintenance of defence against pathogenic gastrointestinal microorganisms.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The Panel considers that the food constituent, Lactobacillus rhamnosus GG (LGG), which is the subject of the health claim, is sufficiently characterised.

The claimed effect is “helps to maintain defence against intestinal pathogens”. The target population proposed by the applicant is the general population (adults and children). The Panel considers that the health claim refers to the defence against intestinal pathogens in the general population without GI infections and does not include the treatment of gastrointestinal (GI) infections. The presence of pathogenic microorganisms in the GI tract may lead to the development of GI infections. Maintenance of the defence against pathogenic GI microorganisms may protect against the development of GI infections. The Panel considers that maintenance of defence against pathogenic GI microorganisms is a beneficial physiological effect.

The applicant submitted a total of 45 human studies and 41 non-human studies for the scientific substantiation of the health claim.

Out of the five human intervention studies which investigated the effect of LGG consumption on the development of GI infections from which conclusions could be drawn for the scientific substantiation of the health claim, one did not show an effect of LGG consumption on the incidence of Traveller’s diarrhoea, one did not show an effect on the incidence or duration of GI infections in free-living children, and two out of three did not show an effect on the incidence or duration of GI infections in hospitalised children. The Panel notes that the evidence provided does not establish that consumption of LGG has an effect on the development of GI infections.

Two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination.

A number of human intervention studies on the effect of LGG consumption on the duration and/or severity of diarrhoea in children with acute diarrhoea due to GI infections, as well as two meta-analyses and one consensus opinion including studies on the treatment of acute diarrhoea were provided. The Panel considers that the evidence provided by the applicant does not establish that results from studies using LGG as coadjutant in the treatment of GI infections provide information about the effect of LGG on the development of GI infections, that results obtained in young children provide information about the adult population, or that results obtained on the treatment of GI infections caused by viruses provide information about other types of GI infections.

Six studies in healthy adults and children under antibiotic treatment and two meta-analyses which included studies on the prevention of antibiotic-induced diarrhoea were presented. The Panel notes that these studies did not provide adequate information about the aetiology of diarrhoeal episodes, and that antibiotic treatment may induce diarrhoea by mechanisms unrelated to GI infections.

One study on the effects of LGG on vancomycin resistant enterococci (VRE) carrier rate in VRE-positive patients under multiple antibiotic treatments in a renal ward from which no conclusions could be drawn for the scientific substantiation of the claims and several human and non-human studies which investigated the mechanisms by which LGG could exert the claimed effect were also provided. The Panel considers that, in the absence of evidence for an effect of LGG consumption on the development of GI infections in the general population that is the target of the health claim, these studies cannot be used as a source of data for the scientific substantiation of the claim because their results cannot predict the occurrence of an effect of LGG on the development of GI infections in vivo in humans.

In weighing the evidence, the Panel took into account that only one out of five human intervention studies showed an effect of LGG consumption on the development of GI infections, and that two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of LGG and maintenance of defence against pathogenic gastrointestinal microorganisms.

Keywords

Lactobacillus rhamnosus GG, gastrointestinal infections, pathogens, acute diarrhea, health claims