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Please use this identifier to cite or link to this item: http://hdl.handle.net/10481/29114

Title: Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study
Authors: 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
Gil Hernández, Ángel
Fontana Gallego, Luis
Issue Date: 2013
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.
Sponsorship: Part 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.
Publisher: Public Library of Science
Keywords: Antibiotics
Safety studies
Clostridium difficile
URI: http://hdl.handle.net/10481/29114
ISSN: 1932-6203
Rights : Creative Commons Attribution-NonCommercial-NoDerivs 3.0 License
Citation: 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]
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