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dc.contributor.authorPlaza Díaz, Julio
dc.contributor.authorGómez Llorente, Carolina
dc.contributor.authorCampaña-Martín, Laura
dc.contributor.authorMatencio, Esther
dc.contributor.authorOrtuño, Inmaculada
dc.contributor.authorMartínez-Silla, Rosario
dc.contributor.authorGómez-Gallego, Carlos
dc.contributor.authorPeriago, María Jesús
dc.contributor.authorRos, Gaspar
dc.contributor.authorChenoll, Empar
dc.contributor.authorGenovés, Salvador
dc.contributor.authorCasino, Beatriz
dc.contributor.authorSilva, Ángela
dc.contributor.authorCorella, Dolores
dc.contributor.authorPortóles, Olga
dc.contributor.authorRomero, Fernando
dc.contributor.authorRamón, Daniel
dc.contributor.authorPérez De La Cruz, Antonio Jesús 
dc.contributor.authorGil Hernández, Ángel 
dc.contributor.authorFontana Gallego, Luis
dc.identifier.citationPlaza-Díaz, J.; et al. Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study. Plos, 8(10): e78111 (2013). []es_ES
dc.identifier.otherdoi: 10.1371/journal.pone.0078111
dc.description.abstractWe 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.es_ES
dc.description.sponsorshipPart of the research currently in progress in the authors' laboratory is funded by the company Hero Spain, S. A. through the grant #3582 managed by the Fundacion General Empresa-Universidad de Granada.es_ES
dc.publisherPublic Library of Sciencees_ES
dc.rightsCreative Commons Attribution-NonCommercial-NoDerivs 3.0 Licensees_ES
dc.subjectAntibiotics es_ES
dc.subjectCytokines es_ES
dc.subjectBlood es_ES
dc.subjectSafety studieses_ES
dc.subjectClostridium difficile es_ES
dc.titleSafety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB studyes_ES

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