Irene Lenoir-Wijnkoop

Guidance for substantiating the evidence for beneficial effects of probiotics: probiotics in chronic inflammatory bowel disease and the functional disorder irritable bowel syndrome.

Ulcerative colitis and Crohns disease, the 2 distinct idiopathic pathologies of inflammatory bowel diseases, are spontaneously relapsing, immunologically mediated disorders of the gastrointestinal tract. Selected probiotics strains have been proven to be clinically effective in maintaining remission in patients with ulcerative colitis. None of the probiotics thus far tested has been shown to be effective in induction of remission or in maintenance of remission in patients with Crohns disease. The multispecies probiotics mixture of 8 strains seems effective in the maintenance of remission in pouchitis. Irritable bowel syndrome is a functional bowel disorder manifested by chronic, recurring abdominal pain or discomfort associated with disturbed bowel habit in the absence of structural abnormalities likely to account for these symptoms. Recently conducted appropriately powered studies with different (combinations of) probiotics show positive results on reduction of symptoms, although a considerable placebo effect is also found. Mechanistic studies aimed at pathophysiological mechanisms of inflammatory bowel diseases can identify new targets for probiotic bacteria.

Monitoring immune modulation by nutrition in the general population: identifying and substantiating effects on human health.

Optimal functioning of the immune system is crucial to human health, and nutrition is one of the major exogenous factors modulating different aspects of immune function. Currently, no single marker is available to predict the effect of a dietary intervention on different aspects of immune function. To provide further guidance on the assessment and interpretation of the modulation of immune functions due to nutrition in the general population, International Life Sciences Institute Europe commissioned a group of experts from academia, government and the food industry to prepare a guidance document. A draft of this paper was refined at a workshop involving additional experts. First, the expert group defined criteria to evaluate the usefulness of immune function markers. Over seventy-five markers were scored within the context of three distinct immune system functions: defence against pathogens; avoidance or mitigation of allergy; control of low-grade (metabolic) inflammation. The most useful markers were subsequently classified depending on whether they by themselves signify clinical relevance and/or involvement of immune function. Next, five theoretical scenarios were drafted describing potential changes in the values of markers compared with a relevant reference range. Finally, all elements were combined, providing a framework to aid the design and interpretation of studies assessing the effects of nutrition on immune function. This stepwise approach offers a clear rationale for selecting markers for future trials and provides a framework for the interpretation of outcomes. A similar stepwise approach may also be useful to rationalise the selection and interpretation of markers for other physiological processes critical to the maintenance of health and well-being.Optimal functioning of the immune system is crucial to human health, and nutrition is one of the major exogenous factors modulating different aspects of immune function. Currently, no single marker is available to predict the effect of a dietary intervention on different aspects of immune function. To provide further guidance on the assessment and interpretation of the modulation of immune functions due to nutrition in the general population, International Life Sciences Institute Europe commissioned a group of experts from academia, government and the food industry to prepare a guidance document. A draft of this paper was refined at a workshop involving additional experts. First, the expert group defined criteria to evaluate the usefulness of immune function markers. Over seventy-five markers were scored within the context of three distinct immune system functions: defence against pathogens; avoidance or mitigation of allergy; control of low-grade (metabolic) inflammation. The most useful markers were subsequently classified depending on whether they by themselves signify clinical relevance and/or involvement of immune function. Next, five theoretical scenarios were drafted describing potential changes in the values of markers compared with a relevant reference range. Finally, all elements were combined, providing a framework to aid the design and interpretation of studies assessing the effects of nutrition on immune function. This stepwise approach offers a clear rationale for selecting markers for future trials and provides a framework for the interpretation of outcomes. A similar stepwise approach may also be useful to rationalise the selection and interpretation of markers for other physiological processes critical to the maintenance of health and well-being.

Probiotics and prebiotics: prospects for public health and nutritional recommendations

Probiotics and prebiotics are useful interventions for improving human health through direct or indirect effects on the colonizing microbiota. However, translation of these research findings into nutritional recommendations and public health policy endorsements has not been achieved in a manner consistent with the strength of the evidence. More progress has been made with clinical recommendations. Conclusions include that beneficial cultures, including probiotics and live cultures in fermented foods, can contribute towards the health of the general population; prebiotics, in part due to their function as a special type of soluble fiber, can contribute to the health of the general population; and a number of challenges must be addressed in order to fully realize probiotic and prebiotic benefits, including the need for greater awareness of the accumulated evidence on probiotics and prebiotics among policy makers, strategies to cope with regulatory roadblocks to research, and high‐quality human trials that address outstanding research questions in the field.

Primary prevention of nephrolithiasis is cost‐effective for a national healthcare system

Study Type – Therapy (cost‐effectiveness meeting)

Increased Water Intake as a Prevention Strategy for Recurrent Urolithiasis: Major Impact of Compliance on Cost-Effectiveness

PURPOSE We evaluated the economic impact of preventing recurrent stones using a strategy of increased water intake and determined the impact of compliance on cost-effectiveness for the French health care system. MATERIALS AND METHODS A Markov model was constructed to compare costs and outcomes for recurrent kidney stone formers with less than 2 L vs 2 L or more daily fluid intake. Model assumptions included an annual prevalence of 120,000 stone episodes in France, 14.4% annual risk of stone recurrence and a 55% risk reduction in subjects with adequate water intake. Costs were based on resource use as estimated by a panel of experts and official national price lists. Outcomes were from the perspective of the public health payer, and encompassed direct and indirect costs. RESULTS The total cost of an episode of urolithiasis was estimated at €4,267 including the cost of treatment and complications. This corresponds to an annual budget impact of €88 million for recurrent stones based on 21,000 stone events. Assuming 100% compliance with fluid intake recommendations of 2 L daily, 11,572 new stones might be prevented, resulting in a cost savings of €49 million. Compliance with water intake in only 25% of patients would still result in 2,893 fewer stones and a cost savings of €10 million. Varying the costs of managing stones had a smaller impact on outcomes since in many patients stones do not form. Varying the incidence of complications did not change the incidence of stones and had a negligible effect on overall cost. CONCLUSIONS Preventing recurrent urolithiasis has a significant cost savings potential for a payer as a result of a reduced stone burden. However, compliance is an important factor in determining cost-effectiveness.

Nutrition economics – characterising the economic and health impact of nutrition

There is a new merging of health economics and nutrition disciplines to assess the impact of diet on health and disease prevention and to characterise the health and economic aspects of specific changes in nutritional behaviour and nutrition recommendations. A rationale exists for developing the field of nutrition economics which could offer a better understanding of both nutrition, in the context of having a significant influence on health outcomes, and economics, in order to estimate the absolute and relative monetary impact of health measures. For this purpose, an expert meeting assessed questions aimed at clarifying the scope and identifying the key issues that should be taken into consideration in developing nutrition economics as a discipline that could potentially address important questions. We propose a first multidisciplinary outline for understanding the principles and particular characteristics of this emerging field. We summarise here the concepts and the observations of workshop participants and propose a basic setting for nutrition economics and health outcomes research as a novel discipline to support nutrition, health economics and health policy development in an evidence and health-benefit-based manner.

Health claims substantiation for probiotic and prebiotic products

The topic of “Health Claims Substantiation for Probiotic and Prebiotic Products” was discussed at the 8th annual International Scientific Association for Probiotics and Prebiotics (ISAPP) meeting. The topic is especially timely considering that the regulatory review process for health benefit claims on probiotic and prebiotic products in Europe has not resulted in a single claim being approved (120 negative opinions on probiotic claims and 19 negative opinions on prebiotic claims through February 2011). This situation in Europe and elsewhere has driven companies to seek clarity on a research path that would stand up to scientific scrutiny as well as satisfy regulatory demands for health claim substantiation. It can be challenging to negotiate rigid regulatory distinctions, such as between health and disease, when these states are more realistically represented by continua. One research approach focused on improved homeostasis is explored as a statistically robust approach to measuring physiological parameters in healthy populations, which are the required target for food and supplement claims. Diverse global regulatory frameworks complicate this issue, and harmonization of different approaches globally would simplify requirements for industry, decrease consumer confusion and improve the scientific framework for the research community to set up appropriate research pathways. This report highlights key points from this discussion.

Health economics and nutrition: a review of published evidence

The relationship between nutrition and health-economic outcomes is important at both the individual and the societal level. While personal nutritional choices affect an individuals health condition, thus influencing productivity and economic contribution to society, nutrition interventions carried out by the state also have the potential to affect economic output in significant ways. This review summarizes studies of nutrition interventions in which health-related economic implications of the intervention have been addressed. Results of the search strategy have been categorized into three areas: economic studies of micronutrient deficiencies and malnutrition; economic studies of dietary improvements; and economic studies of functional foods. The findings show that a significant number of studies have calculated the health-economic impacts of nutrition interventions, but approaches and methodologies are sometimes ad hoc in nature and vary widely in quality. Development of an encompassing economic framework to evaluate costs and benefits from such interventions is a potentially fruitful area for future research.

Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics

Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re‐confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy.

Nutrition economics – food as an ally of public health

Non-communicable diseases (NCD) are a major and increasing contributor to morbidity and mortality in developed and developing countries. Much of the chronic disease burden is preventable through modification of lifestyle behaviours, and increased attention is being focused on identifying and implementing effective preventative health strategies. Nutrition has been identified as a major modifiable determinant of NCD. The recent merging of health economics and nutritional sciences to form the nascent discipline of nutrition economics aims to assess the impact of diet on health and disease prevention, and to evaluate options for changing dietary choices, while incorporating an understanding of the immediate impacts and downstream consequences. In short, nutrition economics allows for generation of policy-relevant evidence, and as such the discipline is a crucial partner in achieving better population nutritional status and improvements in public health and wellness. The objective of the present paper is to summarise presentations made at a satellite symposium held during the 11th European Nutrition Conference, 28 October 2011, where the role of nutrition and its potential to reduce the public health burden through alleviating undernutrition and nutrition deficiencies, promoting better-quality diets and incorporating a role for functional foods were discussed.