PMID- 22970150
OWN - NLM
STAT- MEDLINE
DCOM- 20130501
LR  - 20221207
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 7
IP  - 9
DP  - 2012
TI  - Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on 
      biomarkers in healthy adults: results from a randomized masked trial.
PG  - e43910
LID - 10.1371/journal.pone.0043910 [doi]
LID - e43910
AB  - BACKGROUND: There are few carefully-designed studies investigating the safety of 
      individual probiotics approved under Investigational New Drug policies. 
      OBJECTIVES: The primary aim of this prospective, double-blind placebo-controlled 
      trial was to investigate if daily treatment of adults with Lactobacillus reuteri 
      DSM 17938 (LR) for 2 months is safe and well-tolerated. Our secondary aim was to 
      determine if LR treatment has immune effects as determined by regulatory T cell 
      percentages, expression of toll-like receptors (TLR)-2 and -4 on circulating 
      peripheral blood mononuclear cells (PMBCs), cytokine expression by stimulated 
      PBMC, and intestinal inflammation as measured by fecal calprotectin. METHODS: 
      Forty healthy adults were randomized to a daily dose of 5 x 10(8) CFUs of LR (n = 
      30) or placebo (n = 10) for 2 months. Participants completed a daily diary card 
      and had 7 clinic visits during treatment and observation. RESULTS: There were no 
      severe adverse events (SAEs) and no significant differences in adverse events 
      (AEs). There were no differences in PBMC subclasses, TLRs, or cytokine expression 
      after treatment. The probiotic-treated group had a significantly higher fecal 
      calprotectin level than the placebo group after 2 months of treatment: 50 microg/g 
      (IQR 24-127 microg/g) vs. 17 microg/g (IQR 11-26 microg/g), p = 0.03, although values 
      remained in the normal clinical range (0-162.9 microg/g). LR vials retained >10(8) 
      CFUs viable organisms/ml. CONCLUSIONS: LR is safe and well tolerated in adults, 
      without significant changes in immunologic markers. There was a small but 
      significant increase in fecal calprotectin, perhaps indicating some element of 
      immune recognition at the intestinal level. TRIAL REGISTRATION: Clinical 
      Trials.gov NCT00922727.
FAU - Mangalat, Nisha
AU  - Mangalat N
AD  - Department of Pediatrics, University of Texas Medical School at Houston, Houston, 
      Texas, United States of America.
FAU - Liu, Yuying
AU  - Liu Y
FAU - Fatheree, Nicole Y
AU  - Fatheree NY
FAU - Ferris, Michael J
AU  - Ferris MJ
FAU - Van Arsdall, Melissa R
AU  - Van Arsdall MR
FAU - Chen, Zhongxue
AU  - Chen Z
FAU - Rahbar, Mohammad H
AU  - Rahbar MH
FAU - Gleason, Wallace A
AU  - Gleason WA
FAU - Norori, Johana
AU  - Norori J
FAU - Tran, Dat Q
AU  - Tran DQ
FAU - Rhoads, J Marc
AU  - Rhoads JM
LA  - eng
SI  - ClinicalTrials.gov/NCT00922727
GR  - P30 DK056338/DK/NIDDK NIH HHS/United States
GR  - U01 AT003519/AT/NCCIH NIH HHS/United States
GR  - UL1 RR024148/RR/NCRR NIH HHS/United States
GR  - NIH/NCCAMU01AT003519/AT/NCCIH NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20120906
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Biomarkers)
RN  - 0 (Cytokines)
RN  - 0 (Leukocyte L1 Antigen Complex)
RN  - 0 (Toll-Like Receptors)
SB  - IM
MH  - Adult
MH  - Biomarkers/*metabolism
MH  - Cytokines/metabolism
MH  - Denaturing Gradient Gel Electrophoresis
MH  - Double-Blind Method
MH  - Feces/microbiology
MH  - Female
MH  - Humans
MH  - Limosilactobacillus reuteri/*metabolism
MH  - Leukocyte L1 Antigen Complex/metabolism
MH  - Leukocytes, Mononuclear/drug effects/metabolism
MH  - Male
MH  - Middle Aged
MH  - Probiotics/administration & dosage/*adverse effects/*pharmacology
MH  - Toll-Like Receptors/metabolism
MH  - Young Adult
PMC - PMC3435331
COIS- Competing Interests: The authors have read the journal's policy and have the 
      following conflicts: JMR was a sponsored speaker (Biogaia, Inc.) at the 2011 
      annual meeting of the Latin American Society of Pediatric Gastorenterology. 
      Biogaia Inc. provided the study product and placebo. There are no patents, 
      products in development or marketed products to declare. This does not alter the 
      authors' adherence to all the PLoS ONE policies on sharing data and materials, as 
      detailed online in the guide for authors.
EDAT- 2012/09/13 06:00
MHDA- 2013/05/02 06:00
PMCR- 2012/09/06
CRDT- 2012/09/13 06:00
PHST- 2012/05/11 00:00 [received]
PHST- 2012/07/26 00:00 [accepted]
PHST- 2012/09/13 06:00 [entrez]
PHST- 2012/09/13 06:00 [pubmed]
PHST- 2013/05/02 06:00 [medline]
PHST- 2012/09/06 00:00 [pmc-release]
AID - PONE-D-12-14097 [pii]
AID - 10.1371/journal.pone.0043910 [doi]
PST - ppublish
SO  - PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.