Bimuno™ and reduction of the bad bacteria that can cause travellers’ diarrhoea - Scientific substantiation of a health claim related to Bimuno™ and reduction of the bad bacteria that can cause travellers’ diarrhoea pursuant to Article 14 of Regulation (EC

Abstract

The scope of the application was proposed to fall under a health claim referring to disease risk reduction.The food supplement, Bimuno TM , a β-galacto-oligosaccharide mixture, that is the subject of the health claim is sufficiently characterised.The claimed effect is "reducing the bad bacteria that can cause travellers' diarrhoea". The target population is adults and young persons (12 years and over). The Panel considers that a decrease in bacterial, viral and parasitic enteric pathogens is beneficial to human health by reducing the risk of travellers' diarrhoea.The applicant identified one (unpublished) double-blind, placebo-controlled, randomised clinical study including 159 adults as being pertinent to the health claim. Healthy adult volunteers were given Bimuno TM or placebo starting seven days prior to reaching the final travel destination. The number of episodes with diarrhoea was lower and the duration of diarrhoea and abdominal pain was significantly shorter in the study group. The Panel notes that the subjects were not sufficiently characterised and that no data on risk factors were provided. Further weaknesses of this study include the high drop-out rate and the insufficient description of statistical analyses. The Panel considers that the weaknesses of this study limit its value as a source of data to substantiate the claimed effect of Bimuno TM .One unpublished study showed that Bimuno TM can suppress Salmonella enterica typhimurium induced clinical and histopathological signs in a mouse model. A further combined in vitro and animal study indicated that Bimuno TM enhances growth of bifidobacteria in vivo in a pig model and can reduce adhesion of Salmonella enterica typhimurium to intestinal cells in vitro. The results from the animal and in vitro studies cannot be extrapolated to humans.On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Bimuno TM and reduction of the bad bacteria that can cause travellers' diarrhoea.