title: Safety of probiotics and synbiotics in children under 18 years of age.
abstract: This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.
authors: 1 VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
authors: M
authors: M
authors: van den Nieuwboer
authors: 2 School of Health and Medical Sciences, Örebro University, 701 82 Örebro, Sweden.
authors: R J
authors: RJ
authors: Brummer
authors: 3 Digestive System Research Unit, CIBERehd, University Hospital Vall d'Hebron, 08035 Barcelona, Spain.
authors: F
authors: F
authors: Guarner
authors: 4 Istituto di Microbiologia, Università Cattolica S.C., Via Emilia Parmense 84, 29122 Piacenza, Italy.
authors: L
authors: L
authors: Morelli
authors: 5 University of California San Francisco (UCSF), Departments of Pediatrics, Epidemiology and Biostatistics, 3333 California Street, #245, San Francisco, CA 94118, USA.
authors: M
authors: M
authors: Cabana
authors: 1 VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.|6 Erasmus Medical Center, Department of Viroscience, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands.
authors: E
authors: E
authors: Claassen
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects*; D058616:Synbiotics / Q000008:administration & dosage* / Q000009:adverse effects*
keywords: prebiotics; probiotics; safety; synbiotics