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Probiotic and synbiotic safety in infants under two years of age
Athena Inst, Vrije Univ Amsterdam, Amsterdam, Netherlands; Swammerdam Inst Life Sci, Univ Amsterdam, Amsterdam, Netherlands.
Athena Inst, Vrije Univ Amsterdam, Amsterdam, Netherlands; Dept Virosci, Erasmus MC, Rotterdam, Netherlands .
Ist Microbiol, Univ Cattolica SC, Piacenza, Italy.
CIBERehd, Digest Syst Res Unit, Univ Hosp Vall dHebron, Barcelona, Spain.
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2014 (English)In: Beneficial Microbes, ISSN 1876-2883, E-ISSN 1876-2891, Vol. 5, no 1, p. 45-60Article in journal (Refereed) Published
Abstract [en]

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

Place, publisher, year, edition, pages
Wageningen: Wageningen Academic Publishers, 2014. Vol. 5, no 1, p. 45-60
Keywords [en]
prebiotics; probiotics; health benefits; food safety legislation; children
National Category
Microbiology in the medical area Nutrition and Dietetics
Identifiers
URN: urn:nbn:se:oru:diva-33867DOI: 10.3920/BM2013.0046ISI: 000333128400006PubMedID: 24463207Scopus ID: 2-s2.0-84894356563OAI: oai:DiVA.org:oru-33867DiVA, id: diva2:698149
Available from: 2014-02-20 Created: 2014-02-20 Last updated: 2018-06-05Bibliographically approved

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Brummer, Robert J

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School of Medicine, Örebro University, SwedenÖrebro University Hospital
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