PMID- 25809217
OWN - NLM
STAT- MEDLINE
DCOM- 20160802
LR  - 20151009
IS  - 1876-2891 (Electronic)
IS  - 1876-2883 (Linking)
VI  - 6
IP  - 5
DP  - 2015
TI  - Safety of probiotics and synbiotics in children under 18 years of age.
PG  - 615-30
LID - 10.3920/BM2014.0157 [doi]
AB  - 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.
FAU - van den Nieuwboer, M
AU  - van den Nieuwboer M
AD  - 1 VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV 
      Amsterdam, the Netherlands.
FAU - Brummer, R J
AU  - Brummer RJ
AD  - 2 School of Health and Medical Sciences, Orebro University, 701 82 Orebro, 
      Sweden.
FAU - Guarner, F
AU  - Guarner F
AD  - 3 Digestive System Research Unit, CIBERehd, University Hospital Vall d'Hebron, 
      08035 Barcelona, Spain.
FAU - Morelli, L
AU  - Morelli L
AD  - 4 Istituto di Microbiologia, Universita Cattolica S.C., Via Emilia Parmense 84, 
      29122 Piacenza, Italy.
FAU - Cabana, M
AU  - Cabana M
AD  - 5 University of California San Francisco (UCSF), Departments of Pediatrics, 
      Epidemiology and Biostatistics, 3333 California Street, #245, San Francisco, CA 
      94118, USA.
FAU - Claassen, E
AU  - Claassen E
AD  - 1 VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV 
      Amsterdam, the Netherlands.
AD  - 6 Erasmus Medical Center, Department of Viroscience, P.O. Box 2040, 3000 CA 
      Rotterdam, the Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20150422
PL  - Netherlands
TA  - Benef Microbes
JT  - Beneficial microbes
JID - 101507616
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Probiotics/*administration & dosage/*adverse effects
MH  - Synbiotics/*administration & dosage/*adverse effects
OTO - NOTNLM
OT  - prebiotics
OT  - probiotics
OT  - safety
OT  - synbiotics
EDAT- 2015/03/27 06:00
MHDA- 2016/08/03 06:00
CRDT- 2015/03/27 06:00
PHST- 2015/03/27 06:00 [entrez]
PHST- 2015/03/27 06:00 [pubmed]
PHST- 2016/08/03 06:00 [medline]
AID - DX732J656QH1Q052 [pii]
AID - 10.3920/BM2014.0157 [doi]
PST - ppublish
SO  - Benef Microbes. 2015;6(5):615-30. doi: 10.3920/BM2014.0157. Epub 2015 Apr 22.