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.Trial RegistrationClinicalTrials.gov NCT01479543
Highlights
The Food and Agriculture Organization (FAO) and the World Health Organization (WHO) define probiotics as live microorganisms that confer a health benefit to the host when administered in adequate amounts [1]
These strains were selected based on their probiotic properties, such as adhesion to intestinal mucus, sensitivity to antibiotics and resistance to biliary salts and low pH. We identified these strains as Lactobacillus paracasei Collection Nationale de Cultures de Microorganismes (CNCM) I-4034, Bifidobacterium breve CNCM I-4035 and Lactobacillus rhamnosus CNCM I-4036 [10]
There was no significant difference between volunteers who received placebo and those fed probiotics regarding height, weight, body mass index, heart rate or blood pressure at baseline
Summary
The Food and Agriculture Organization (FAO) and the World Health Organization (WHO) define probiotics as live microorganisms that confer a health benefit to the host when administered in adequate amounts [1]. The FAO/WHO [1] and the European Union (EU)-funded Product Safety Enforcement Forum of Europe (EU-PROSAFE) project [7] have attempted to create consensus guidelines for probiotic safety evaluation. These groups have recommended that i) the genus and species of the microorganism must first be definitively determined by phenotypic and genotypic techniques, ii) the strains must be deposited in an internationally recognized culture collection, and iii) the safety of the bacterial strain must be evaluated through acute ingestion studies in murine models and the estimation of potential side effects in human studies. The criteria for the selection of probiotics include tolerance to gastrointestinal conditions (gastric acid and bile), ability to adhere to the gastrointestinal mucosa and competitive exclusion of pathogens [8,9]
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