Risk-benefit assessment of nutritional immune interventions during early life

Background: The immune health status is strongly determined during early life stages. Many immune-related diseases are thought to find their origin in adverse shifts in immune balances during pregnancy or the first 2-3 years of life, including atopic diseases. Therefore, immune health interventions during these stages of life may be most effective in reducing the loss of health, loss of quality of life and costs to society due to immune-related diseases and disorders. Several starting points for immune health interventions have been identified and are being developed into prophylactic or therapeutic approaches, particularly targeted at the early life stages. Unfortunately, there is no consensus on which parameters should be addressed to assess the safety and/or efficacy of the interventions and how all the available data should be interpreted at the end. Hence, it would be extremely helpful to address this issue by developing a pragmatic, flexible and science-based risk-benefit assessment. Method: We adapted the risk-benefit approach published by Renwick et al. (2004), to develop a framework for riskbenefit assessment of immune health interventions during early life stages. As case studies, we collected all available in vitro/vivo/silico and human data on galacto-oligosaccharides and fructo-oligosaccharides. Results: The severity of hazard and beneficial effects observed and the incidence at which such an effect may be considered acceptable, were used to weigh the risk and beneficial effects. This risk-benefit framework enables us to evaluate all intervention data available and forms the basis to derive the optimal dose levels of intake. Conclusion: This novel approach enables risk assessors to take the multitude of different types of data available covering toxicity and efficacy studies into account, by ranking and weighing all available data. Ultimately, this assessment will help to determine optimal beneficial and safe dose levels of intake.