Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial
| Autor: | J. Marc Rhoads, Yuying Liu, Mohammad H. Rahbar, Wallace A. Gleason, Johana Norori, Nicole Y. Fatheree, Zhongxue Chen, Dat Q. Tran, Nisha Mangalat, Michael J. Ferris, Melissa R Van Arsdall |
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| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Limosilactobacillus reuteri
Male Anatomy and Physiology Applied Microbiology Digestive Physiology lcsh:Medicine law.invention Feces 0302 clinical medicine Cytokines metabolism Randomized controlled trial law Pathology Gastrointestinal Infections lcsh:Science 0303 health sciences Multidisciplinary biology T Cells Toll-Like Receptors Middle Aged 3. Good health Infectious Diseases Tolerability Medical Microbiology Cytokines Medicine Female 030211 gastroenterology & hepatology Research Article Biotechnology Adult Drugs and Devices medicine.medical_specialty Clinical Pathology Clinical Research Design Immune Cells Immunology Gastroenterology and Hepatology Microbiology Microbial Ecology Immunomodulation Young Adult 03 medical and health sciences Double-Blind Method Complementary and Alternative Medicine Adverse Reactions Diagnostic Medicine Internal medicine medicine Humans Clinical Trials Adverse effect Biology Nutrition 030304 developmental biology Inflammation Denaturing Gradient Gel Electrophoresis Extramural business.industry Probiotics lcsh:R Immunity Investigational New Drug biology.organism_classification Lactobacillus reuteri Clinical Microbiology Leukocytes Mononuclear Clinical Immunology lcsh:Q business Leukocyte L1 Antigen Complex Digestive System Biomarkers |
| Zdroj: | PLoS ONE, Vol 7, Iss 9, p e43910 (2012) PLoS ONE |
| ISSN: | 1932-6203 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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