Save

Safety of probiotics and synbiotics in children under 18 years of age

In: Beneficial Microbes
Authors:
M. van den Nieuwboer VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands

Search for other papers by M. van den Nieuwboer in
Current site
Google Scholar
PubMed
Close
,
R.J. Brummer School of Health and Medical Sciences, Örebro University, 701 82 Örebro, Sweden

Search for other papers by R.J. Brummer in
Current site
Google Scholar
PubMed
Close
,
F. Guarner Digestive System Research Unit, CIBERehd, University Hospital Vall d’Hebron, 08035 Barcelona, Spain

Search for other papers by F. Guarner in
Current site
Google Scholar
PubMed
Close
,
L. Morelli Istituto di Microbiologia, Università Cattolica S.C., Via Emilia Parmense 84, 29122 Piacenza, Italy

Search for other papers by L. Morelli in
Current site
Google Scholar
PubMed
Close
,
M. Cabana University of California San Francisco (UCSF), Departments of Pediatrics, Epidemiology and Biostatistics, 3333 California Street, #245, San Francisco, CA 94118, USA

Search for other papers by M. Cabana in
Current site
Google Scholar
PubMed
Close
, and
E. Claassen VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands
Erasmus Medical Center, Department of Viroscience, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands

Search for other papers by E. Claassen in
Current site
Google Scholar
PubMed
Close
Open Access

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.

Content Metrics

All Time Past 365 days Past 30 Days
Abstract Views 20 20 0
Full Text Views 271 259 71
PDF Views & Downloads 262 256 58