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Safety of probiotics and synbiotics in children under 18 years of age
Athena Institute, Vrije University, Amsterdam, the Netherlands.
Örebro University, School of Medicine, Örebro University, Sweden.ORCID iD: 0000-0002-0362-0008
Digestive System Research Unit, CIBERehd, University Hospital Vall d’Hebron, Barcelona, Spain.
Istituto di Microbiologia, Università Cattolica S.C., Piacenza, Italy.
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2015 (English)In: Beneficial Microbes, ISSN 1876-2883, E-ISSN 1876-2891, Vol. 6, no 5, p. 615-630Article in journal (Refereed) Published
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Abstract [en]

This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.

Place, publisher, year, edition, pages
Wageningen Academic Publishers, 2015. Vol. 6, no 5, p. 615-630
Keywords [en]
probiotics, synbiotics, children, safety, prebiotics
National Category
Microbiology Nutrition and Dietetics
Research subject
Microbiology; Nutrition
Identifiers
URN: urn:nbn:se:oru:diva-47696DOI: 10.3920/BM2014.0157ISI: 000367306800001PubMedID: 25809217Scopus ID: 2-s2.0-84944404934OAI: oai:DiVA.org:oru-47696DiVA, id: diva2:896005
Available from: 2016-01-20 Created: 2016-01-20 Last updated: 2018-07-02Bibliographically approved

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Brummer, Robert Jan

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