EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to Bimuno® GOS and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

the the on Products, Nutrition and Allergies to deliver an on the scientific substantiation of a health claim related to Bimuno ® GOS and reducing gastro-intestinal discomfort. The food constituent that is the subject of the health claim, Bimuno ® GOS, which is a mixture of β-galacto-oligosaccharides produced through conversion of lactose by enzymes from Bifidobacterium bifidum NCIMB 41171, is sufficiently characterised. The claimed effect is reducing gastro-intestinal discomfort and is considered to be a beneficial physiological effect. The applicant did not provide any studies from which data could be used for the scientific substantiation of the claimed effect of reducing gastro-intestinal discomfort. A cause and effect relationship has not been established between the consumption of Bimuno ® GOS and reducing gastro-intestinal discomfort. gastro-intestinal assessment of symptoms used to characterise the study population (flatulence, abdominal pain, abdominal bloating and bowel movement urgency) at baseline has been recommended as the primary outcome of efficacy (on which the main results should be based) for trials investigating functional gastro-intestinal disorders in the consensus opinion provided by the applicant and others published thereafter. The Panel notes that the effect of Bimuno ® GOS on the subjective global assessment of symptoms, a combined measure of efficacy which would indicate whether the intervention provided adequate relief of symptoms of gastro-intestinal discomfort, was not assessed, and that measures of individual gastro-intestinal symptoms through validated questionnaires may only be used as supportive evidence for the scientific substantiation of health claims on the reduction of gastro-intestinal discomfort. In addition, the Panel notes the reported effects of Bimuno ® GOS on three out of the five individual outcomes investigated (i.e. abdominal pain, bloating and flatulence, but not in “bowel movements” or stool consistency) did not translate into a significant improvement of the subjects’ quality of life, which revels inconsistency in the results. The Panel considers that this study does not provide information about the effect of Bimuno ® GOS on relieving subjects from gastro-intestinal discomfort. The Panel concludes that a cause and effect relationship has not been established between the consumption of Bimuno ® GOS and reducing gastro-intestinal discomfort. questionnaires used, the applicant provided the forms that were completed on a daily and weekly basis to collect information on “bowel movements”, abdominal pain, bloating, flatulence, and stool consistency (recorded only in the daily questionnaire). Different scales were used in the daily and weekly questionnaires to describe abdominal symptoms. In the daily questionnaires, number of “bowel movements” was recorded; a scale from “0 = none” to “6 = preventing normal daily activity” was used for abdominal pain, bloating, flatulence; a scale from “1 = hard” to “4 = watery” was used for stool consistency. In the weekly questionnaire, a generic indication that “0 means none” and “6 means a lot” was used to describe the difficulty experienced in relation to bowel movements, and flatulence, whereas a generic indication that “0 means not at all” and “6 means very” was used to describe the severity of symptoms for abdominal pain, and bloating. Another scale from “0 = none” to “3 = severe” was used to describe symptoms related to several factors including flatulence. The on-line forms used for the “quality of life questionnaires” were also provided.