PMID- 26689224
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20221207
IS  - 1876-2891 (Electronic)
IS  - 1876-2883 (Linking)
VI  - 7
IP  - 2
DP  - 2016
TI  - Absence of adverse events in healthy individuals using probiotics--analysis of 
      six randomised studies by one study group.
PG  - 161-9
LID - 10.3920/BM2015.0096 [doi]
AB  - Consumption of live bacteria as probiotic supplements is increasing. There is, 
      however, a lack of information on the safety of ingested probiotics. The main 
      objective of this study was to investigate the adverse events (AEs) of specific 
      probiotics (Lactobacillus rhamnosus GG (LGG) alone or LGG in combination with L. 
      rhamnosus Lc705, Propionibacterium freudenreichii JS, Bifidobacterium lactis 
      BB12, or Bifidobacterium breve 99) studied in six of our study groups' clinical 
      trials, by analysing individual participant data. A secondary objective was to 
      study AEs associated with the consumed probiotic species and mixtures in three 
      specific categories; 'gastrointestinal disorders', 'respiratory, thoracic and 
      mediastinal disorders' and 'infections and infestations'. Six randomised, 
      double-blind, placebo-controlled clinical studies by our study group were 
      included in this AE analysis (study population n=1,909). All AE data were 
      classified according to the National Cancer Institute's Common Terminology 
      Criteria for Adverse Events (CTCAE) v4.0. From the 26 CTCAE System Organ Classes, 
      we identified AEs in 20 classes among 1,909 subjects. Probiotic ingestion did not 
      result in statistically significant differences in AEs in different groups, when 
      compared to placebo. A subgroup analysis of gastrointestinal, respiratory, 
      thoracic and mediastinal disorders, infections and infestations, found no 
      differences between the intervention groups or for different probiotic 
      combinations (risk ratio (RR) = 0.97, 95% confidence interval (CI): 0.93-1.02, 
      P=0.30; RR=0.99, 95% CI: 0.97-1.01, P=0.35; RR=0.99, 95% CI: 0.93-1.06, P=0.62, 
      respectively). As a conclusion, ingestion of probiotic supplementations 
      containing LGG alone, or LGG in combination with L. rhamnosus Lc705, P. 
      freudenreichii JS, B. breve 99, or B. lactis BB12 did not seem to cause AEs in 
      young and elderly subjects in this analysis.
FAU - Tapiovaara, L
AU  - Tapiovaara L
AD  - 1 Otorhinolaryngology, University of Helsinki and Helsinki University Hospital, 
      P.O. Box 220, 00290 Helsinki, Finland.
FAU - Lehtoranta, L
AU  - Lehtoranta L
AD  - 2 Medical Nutrition Physiology, Pharmacology, Faculty of Medicine, University of 
      Helsinki, P.O. Box 64, 00014 Helsinki, Finland.
FAU - Poussa, T
AU  - Poussa T
AD  - 3 STAT-Consulting, Vahverokatu 6, 37130 Nokia, Finland.
FAU - Makivuokko, H
AU  - Makivuokko H
AD  - 4 Makivuokko Consulting, Kaksosvuorentie 20, 02400 Kirkkonummi, Finland.
FAU - Korpela, R
AU  - Korpela R
AD  - 2 Medical Nutrition Physiology, Pharmacology, Faculty of Medicine, University of 
      Helsinki, P.O. Box 64, 00014 Helsinki, Finland.
FAU - Pitkaranta, A
AU  - Pitkaranta A
AD  - 1 Otorhinolaryngology, University of Helsinki and Helsinki University Hospital, 
      P.O. Box 220, 00290 Helsinki, Finland.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20151221
PL  - Netherlands
TA  - Benef Microbes
JT  - Beneficial microbes
JID - 101507616
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bifidobacterium/physiology
MH  - Child, Preschool
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Infant
MH  - Lactobacillus/physiology
MH  - Lacticaseibacillus rhamnosus/physiology
MH  - Male
MH  - Probiotics/administration & dosage/*adverse effects
MH  - Propionibacterium/physiology
MH  - Randomized Controlled Trials as Topic
MH  - Young Adult
OTO - NOTNLM
OT  - Bifidobacterium
OT  - Lactobacillus
OT  - probiotics
OT  - safety
EDAT- 2015/12/23 06:00
MHDA- 2016/12/15 06:00
CRDT- 2015/12/23 06:00
PHST- 2015/12/23 06:00 [entrez]
PHST- 2015/12/23 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.3920/BM2015.0096 [doi]
PST - ppublish
SO  - Benef Microbes. 2016;7(2):161-9. doi: 10.3920/BM2015.0096. Epub 2015 Dec 21.