title: Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01479543.
authors.affiliation: Department of Biochemistry & Molecular Biology II, School of Pharmacy, University of Granada, Granada, Spain ; Institute of Nutrition & Food Technology "José Mataix", Biomedical Research Center, University of Granada, Granada, Spain.
authors.forename: Julio
authors.initials: J
authors.lastname: Plaza-Diaz
authors.forename: Carolina
authors.initials: C
authors.lastname: Gomez-Llorente
authors.forename: Laura
authors.initials: L
authors.lastname: Campaña-Martin
authors.forename: Esther
authors.initials: E
authors.lastname: Matencio
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Ortuño
authors.forename: Rosario
authors.initials: R
authors.lastname: Martínez-Silla
authors.forename: Carlos
authors.initials: C
authors.lastname: Gomez-Gallego
authors.forename: Maria Jesús
authors.initials: MJ
authors.lastname: Periago
authors.forename: Gaspar
authors.initials: G
authors.lastname: Ros
authors.forename: Empar
authors.initials: E
authors.lastname: Chenoll
authors.forename: Salvador
authors.initials: S
authors.lastname: Genovés
authors.forename: Beatriz
authors.initials: B
authors.lastname: Casinos
authors.forename: Angela
authors.initials: A
authors.lastname: Silva
authors.forename: Dolores
authors.initials: D
authors.lastname: Corella
authors.forename: Olga
authors.initials: O
authors.lastname: Portolés
authors.forename: Fernando
authors.initials: F
authors.lastname: Romero
authors.forename: Daniel
authors.initials: D
authors.lastname: Ramón
authors.forename: Antonio
authors.initials: A
authors.lastname: Perez de la Cruz
authors.forename: Angel
authors.initials: A
authors.lastname: Gil
authors.forename: Luis
authors.initials: L
authors.lastname: Fontana
mesh_terms: D000328:Adult; D001644:Bifidobacterium / Q000276:immunology*; D001942:Breast Feeding; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000032:analysis; D007155:Immunologic Factors / Q000009:adverse effects / Q000494:pharmacology*; D016753:Interleukin-10 / Q000032:analysis; D015847:Interleukin-4 / Q000032:analysis; D007778:Lactobacillus / Q000276:immunology*; D052201:Lacticaseibacillus rhamnosus / Q000276:immunology*; D019936:Probiotics / Q000009:adverse effects* / Q000494:pharmacology*
chemical_list: D007070:Immunoglobulin A; D007155:Immunologic Factors; D016753:Interleukin-10; D015847:Interleukin-4