Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study Plaza Díaz, Julio Gómez Llorente, Carolina Campaña-Martín, Laura Matencio, Esther Ortuño, Inmaculada Martínez-Silla, Rosario Gómez-Gallego, Carlos Periago, María Jesús Ros, Gaspar Chenoll, Empar Genovés, Salvador Casino, Beatriz Silva, Ángela Corella, Dolores Portóles, Olga Romero, Fernando Ramón, Daniel Pérez De La Cruz, Antonio Jesús Gil Hernández, Ángel Fontana Gallego, Luis Antibiotics Cytokines Lactobacillus Blood Probiotics Safety studies Bifidobacterium Clostridium difficile 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. 2013-11-15T08:12:20Z 2013-11-15T08:12:20Z 2013 info:eu-repo/semantics/article Plaza-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). [http://hdl.handle.net/10481/29114] 1932-6203 doi: 10.1371/journal.pone.0078111 http://hdl.handle.net/10481/29114 eng http://creativecommons.org/licenses/by-nc-nd/3.0/ info:eu-repo/semantics/openAccess Creative Commons Attribution-NonCommercial-NoDerivs 3.0 License Public Library of Science