Safety and Immunomodulatory Effects of Three Probiotic Strains Isolated from the Feces of Breast-Fed Infants in Healthy Adults: SETOPROB Study
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UNLABELLED: 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 REGISTRATION: ClinicalTrials.gov NCT01479543.
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Probiotics have been shown to induce both pro- and anti-inflammatory responses.
“Such organisms are often used as treatments for conditions with an inflammatory component (e.g., infectious diarrhea, atopic dermatitis, IBD, migraine), however their true functionality is more nuanced, as they have been shown to induce both pro- (Chiba et al., 2010) and anti-inflammatory (Plaza-diaz et al., 2013) responses.”
From Viral Infections, the Microbiome, and Probiotics (2021) · cites this paper as Plaza-diaz et al., 2013
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- Authors
- Plaza-Diaz, J., Gomez-Llorente, C., Campaña-Martin, L., Matencio, E., Ortuño, I., Martínez-Silla, R., Gomez-Gallego, C., Periago, M. J., Ros, G., Chenoll, E., Genovés, S., Casinos, B., Silva, Á., Corella, D., Portolés, O., Romero, F., Ramón, D., Perez de la Cruz, A., Gil, A., & Fontana, L.
- Affiliations
- Hero España (Spain) (ES)
- Universidad de Murcia (ES)
- Universitat de València (ES)
- Universidad de Granada (ES)
- Corresponding author
- Fontana, Luis
- ORCID
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2013-10-28
- Volume
- 8
- Issue
- 10
- Pages
- e78111
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3810271
- OpenAlex
- W2169966827
- Cited by
- 44
- References
- 32
- Citations by year
- 2025: 3 · 2024: 5 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 3 · 2019: 4 · 2018: 4 · 2017: 8 · 2016: 2 · 2015: 3 · 2014: 1
- FWCI
- 2.98
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Institutional Repository of the University of Granada (University of Granada) (submittedVersion, cc-by-nc-nd)
- Digitum: Institutional Repository of the University of Murcia (University of Murcia) (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Hispana (submittedVersion, other-oa)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- Universidad de Granada
- Consejo Superior de Investigaciones Científicas
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, breast-fed infants, probiotic safety, immunomodulation, intestinal colonization, interleukins, fecal microbiota, healthy adults
- MeSH terms
- Adult, Bifidobacterium, Breast Feeding, Double-Blind Method, Feces, Female, Humans, Immunoglobulin A, Immunologic Factors, Lactobacillus, Interleukin-4, Interleukin-10, Probiotics, Lacticaseibacillus rhamnosus
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