Probiotic and synbiotic safety in infants under two years of age.
In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.
Athena Institute, VU University Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands Swammerdam Institute for Life Sciences, University of Amsterdam, Kruislaan 318, 1098 SM Amsterdam, the Netherlands.
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van den Nieuwboer
Athena Institute, VU University Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands Department of Viroscience, Erasmus Medical Center, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands.
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E
Claassen
Istituto di Microbiologia Università Cattolica S.C., Food Microbiology and Biotechnology, Via Emilia Parmense 84, 29122 Piacenza, Italy.
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Morelli
Digestive System Research Unit, CIBERehd, University Hospital Vall d'Hebron, 08035 Barcelona, Spain.
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F
Guarner
hool of Health and Medical Sciences, Faculty of Medicine and Health, Örebro University, 701 82 Örebro, Sweden.
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RJ
Brummer
D001644:Bifidobacterium; D064806:Dysbiosis / Q000628:therapy; D059022:Food Safety; D041981:Gastrointestinal Tract / Q000382:microbiology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007778:Lactobacillus; D019936:Probiotics / Q000009:adverse effects* / Q000627:therapeutic use*; D058616:Synbiotics / Q000009:adverse effects*
children; food safety legislation; health benefits; prebiotics; probiotics