Safety and Tolerability of Lactobacillus reuteri DSM 17938 and Effects on Biomarkers in Healthy Adults: Results from a Randomized Masked Trial

Nisha Mangalat, Yuying Liu, Nicole Y Fatheree, Michael J Ferris, Melissa R Van Arsdall, Zhongxue Chen, Mohammad H Rahbar, Wallace A Gleason, Johana Norori, Dat Q Tran and J Marc Rhoads

PLOS ONE, 2012, vol. 7, issue 9, 1-13

Abstract: 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 5×108 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 µg/g (IQR 24–127 µg/g) vs. 17 µg/g (IQR 11–26 µg/g), p = 0.03, although values remained in the normal clinical range (0–162.9 µg/g). LR vials retained >108 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

Date: 2012
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0043910

DOI: 10.1371/journal.pone.0043910

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