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Title: Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study.
Authors: Plaza-Diaz, Julio
Gomez-Llorente, Carolina
Campaña-Martin, Laura
Matencio, Esther
Ortuño, Inmaculada
Martínez-Silla, Rosario
Gomez-Gallego, Carlos
Periago, Maria Jesús
Ros, Gaspar
Chenoll, Empar
Genovés, Salvador
Casinos, Beatriz
Silva, Angela
Corella, Dolores
Portolés, Olga
Romero, Fernando
Ramón, Daniel
Perez de la Cruz, Antonio
Gil, Angel
Fontana, Luis
metadata.dc.contributor.authoraffiliation: [Plaza-Diaz,J;Gomez-Llorente,Carolina; Gil,A; Fontana,L] Department of Biochemistry & Molecular Biology II, School of Pharmacy, University of Granada, Granada, Spain. [Plaza-Diaz,J; Gomez-Llorente,C; Campaña-Martin,L; Gil,A; Fontana,L] Institute of Nutrition & Food Technology “José Mataix”, Biomedical Research Center, University of Granada, Granada, Spain. [Matencio,E; Ortuño,I; Martinez-Silla,R; Romero,F] Hero Global Technology Center, Hero Spain, S.A., Alcantarilla, Murcia, Spain. [Gomez-Gallego,C; Periago,MJ; Ros,G] Department of Human Nutrition and Food Science, Faculty of Veterinary Sciences, University of Murcia, Murcia, Spain. [Chenoll,E; Genovés,S; Casinos,B; Silva,A; Ramón,D] Department of Food Biotechnology, Biopolis s.l., Parc Científic Universitat de Valencia, Paterna, Valencia, Spain. [Corella,D; Portolés,O] Department of Preventive Medicine and Public Health, School of Medicine, University of Valencia, Valencia, Spain. CIBER Fisiopatologia de la Obesidad y Nutricion, Instituto de Salud Carlos III, Madrid, Spain. [Perez de la Cruz,A] Unit of Nutrition and Dietetics, Virgen de las Nieves Hospital, Granada, Spain.
Keywords: Clostridium difficile;Hibridación in Situ;ARN Bacteriano;Sondas de Oligonucleótidos;Bifidobacterium;Lactobacillus;Microbiota
metadata.dc.subject.mesh: Medical Subject Headings::Organisms::Bacteria::Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Rods::Clostridium::Clostridium difficile
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Histocytological Preparation Techniques::Staining and Labeling::In Situ Hybridization
Medical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNA::RNA, Bacterial
Medical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Nucleic Acid Probes::Oligonucleotide Probes
Medical Subject Headings::Anatomy::Fluids and Secretions::Feces
Medical Subject Headings::Organisms::Bacteria::Gram-Positive Bacteria::Actinobacteria::Bifidobacterium
Medical Subject Headings::Phenomena and Processes::Physiological Phenomena::Nutritional Physiological Phenomena::Child Nutritional Physiological Phenomena::Infant Nutritional Physiological Phenomena::Breast Feeding
Medical Subject Headings::Organisms::Bacteria::Gram-Positive Bacteria::Lactobacillales::Lactobacillaceae::Lactobacillus
Medical Subject Headings::Phenomena and Processes::Biological Phenomena::Ecological and Environmental Phenomena::Environment::Ecosystem::Biodiversity::Biota::Microbiota
Issue Date: 28-Oct-2013
Publisher: Public Library of Science
Citation: Plaza-Diaz J, Gomez-Llorente C, Campaña-Martin L, Matencio E, Ortuño I, Martínez-Silla R, et al. Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study. PLoS ONE. 2013,;8(10):e78111
Abstract: We previously described the isolation and characterization of three probiotic strains from the feces of exclusively breast-fed newborn infants: Lactobacillus paracasei CNCM I-4034, Bifidobacterium breve CNCM I-4035 and Lactobacillus rhamnosus CNCM I-4036. These strains were shown to adhere to intestinal mucus in vitro, to be sensitive to antibiotics and to resist biliary salts and low pH. In the present study, a multicenter, randomized, double-blind, placebo-controlled trial with 100 healthy volunteers in three Spanish cities was carried out to evaluate the tolerance, safety, gut colonization and immunomodulatory effects of these three probiotics. Volunteers underwent a 15-day washout period, after which they were randomly divided into 5 groups that received daily a placebo, a capsule containing one of the 3 strains or a capsule containing a mixture of two strains for 30 days. The intervention was followed by another 15-day washout period. Patients did not consume fermented milk for the entire duration of the study. Gastrointestinal symptoms, defecation frequency and stool consistency were not altered by probiotic intake. No relevant changes in blood and serum, as well as no adverse events occurred during or after treatment. Probiotic administration slightly modified bacterial populations in the volunteers' feces. Intestinal persistence occurred in volunteers who received L. rhamnosus CNCM I-4036. Administration of B. breve CNCM I-4035 resulted in a significant increase in fecal secretory IgA content. IL-4 and IL-10 increased, whereas IL-12 decreased in the serum of volunteers treated with any of the three strains. These results demonstrate that the consumption of these three bacterial strains was safe and exerted varying degrees of immunomodulatory effects.
Description: Trial Registration: NCT01479543
metadata.dc.identifier.doi: 10.1371/journal.pone.0078111
ISSN: 1932-6203 (Online)
Appears in Collections:01- Artículos - Hospital Virgen de las Nieves

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