RT Journal Article
T1 Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study.
A1 Plaza-Diaz, Julio
A1 Gomez-Llorente, Carolina
A1 Campaña-Martin, Laura
A1 Matencio, Esther
A1 Ortuño, Inmaculada
A1 Martínez-Silla, Rosario
A1 Gomez-Gallego, Carlos
A1 Periago, Maria Jesús
A1 Ros, Gaspar
A1 Chenoll, Empar
A1 Genovés, Salvador
A1 Casinos, Beatriz
A1 Silva, Angela
A1 Corella, Dolores
A1 Portolés, Olga
A1 Romero, Fernando
A1 Ramón, Daniel
A1 Perez de la Cruz, Antonio
A1 Gil, Angel
A1 Fontana, Luis
K1 Clostridium difficile
K1 Hibridación in Situ
K1 ARN Bacteriano
K1 Sondas de Oligonucleótidos
K1 Bifidobacterium
K1 Lactobacillus
K1 Microbiota
AB 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.
PB Public Library of Science
YR 2013
FD 2013-10-28
LK http://hdl.handle.net/10668/1645
UL http://hdl.handle.net/10668/1645
LA en
NO 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
NO Trial Registration: ClinicalTrials.gov NCT01479543
DS RISalud
RD Apr 11, 2025