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The administration of probiotics and synbiotics in immune compromised adults: is it safe?
VU University Amsterdam, Athena Institute, Amsterdam, Netherlands .
Örebro University, School of Medicine, Örebro University, Sweden.ORCID iD: 0000-0002-0362-0008
Food Microbiology and Biotechnology 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 1, 3-17 p.Article in journal (Refereed) Published
Abstract [en]

This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (>= 18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability 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. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.

Place, publisher, year, edition, pages
2015. Vol. 6, no 1, 3-17 p.
Keyword [en]
food safety legislation, immunocompromised people, prebiotics, probiotics, synbiotics
National Category
Microbiology Nutrition and Dietetics
Research subject
Microbiology; Nutrition
Identifiers
URN: urn:nbn:se:oru:diva-44866DOI: 10.3920/BM2014.0079ISI: 000354633300002PubMedID: 25304690Scopus ID: 2-s2.0-84920969881OAI: oai:DiVA.org:oru-44866DiVA: diva2:818828
Available from: 2015-06-09 Created: 2015-06-09 Last updated: 2017-10-17Bibliographically approved

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Brummer, Robert J.
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School of Medicine, Örebro University, Sweden
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