PMID- 22425689
OWN - NLM
STAT- MEDLINE
DCOM- 20121009
LR  - 20221207
IS  - 1873-6351 (Electronic)
IS  - 0278-6915 (Linking)
VI  - 50
IP  - 6
DP  - 2012 Jun
TI  - Evaluation of safety and tolerance of microencapsulated Lactobacillus reuteri 
      NCIMB 30242 in a yogurt formulation: a randomized, placebo-controlled, 
      double-blind study.
PG  - 2216-23
LID - 10.1016/j.fct.2012.03.010 [doi]
AB  - Probiotic organisms have shown promise in treating diseases. Previously, we have 
      reported on the efficacy of microencapsulated Lactobacillus reuteri NCIMB 30242 
      in a yogurt formulation at lowering serum cholesterol levels in otherwise healthy 
      hypercholesterolemic adults. This study investigates the safety and toxicology of 
      oral ingestion of microencapsulated L. reuteri NCIMB 30242 in a yogurt 
      formulation. A randomized group of 120 subjects received a dose of 5 x 10(10) CFU 
      microencapsulated L. reuteri NCIMB 30242 in yogurt (n=59) or placebo yogurt 
      (n=61) twice/day for 6 weeks. Clinical chemistry and hematological parameters of 
      safety were analyzed. Fecal samples were collected at these time points for the 
      analysis of deconjugated bile acids. The frequency, duration and intensity of 
      adverse events (AEs) and clinical significance of safety parameters were recorded 
      for both groups. No clinically significant differences between the probiotic 
      yogurt and placebo yogurt treated groups were detected in either the blood 
      clinical chemistry or hematology results and there was no significant increase in 
      fecal deconjugated bile acids (P>0.05) between treated and control groups. The 
      frequency and intensity of AEs was similar in the two groups. These results 
      demonstrate the safe use of this formulation in food.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Jones, Mitchell L
AU  - Jones ML
AD  - Biomedical Technology and Cell Therapy Research Laboratory, Department of 
      Biomedical Engineering, Faculty of Medicine, McGill University, 3775 University 
      Street, Montreal, Quebec, H3A2B4, Canada. mitchell.jones@mcgill.ca
FAU - Martoni, Christopher J
AU  - Martoni CJ
FAU - Tamber, Sandeep
AU  - Tamber S
FAU - Parent, Mathieu
AU  - Parent M
FAU - Prakash, Satya
AU  - Prakash S
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120315
PL  - England
TA  - Food Chem Toxicol
JT  - Food and chemical toxicology : an international journal published for the British 
      Industrial Biological Research Association
JID - 8207483
RN  - 0 (Bile Acids and Salts)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Bile Acids and Salts/analysis
MH  - Blood Cell Count
MH  - Blood Chemical Analysis
MH  - Body Mass Index
MH  - Body Weight
MH  - Double-Blind Method
MH  - Drug Compounding
MH  - Feces/chemistry/microbiology
MH  - Female
MH  - Fermentation
MH  - Hemodynamics/physiology
MH  - Humans
MH  - Hypercholesterolemia/diet therapy
MH  - *Limosilactobacillus reuteri
MH  - Male
MH  - Middle Aged
MH  - Probiotics/administration & dosage/*adverse effects/pharmacokinetics
MH  - Yogurt/*adverse effects/microbiology
MH  - Young Adult
EDAT- 2012/03/20 06:00
MHDA- 2012/10/10 06:00
CRDT- 2012/03/20 06:00
PHST- 2012/01/09 00:00 [received]
PHST- 2012/03/01 00:00 [revised]
PHST- 2012/03/05 00:00 [accepted]
PHST- 2012/03/20 06:00 [entrez]
PHST- 2012/03/20 06:00 [pubmed]
PHST- 2012/10/10 06:00 [medline]
AID - S0278-6915(12)00194-9 [pii]
AID - 10.1016/j.fct.2012.03.010 [doi]
PST - ppublish
SO  - Food Chem Toxicol. 2012 Jun;50(6):2216-23. doi: 10.1016/j.fct.2012.03.010. Epub 
      2012 Mar 15.