title: The administration of probiotics and synbiotics in immune compromised adults: is it safe?
abstract: 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.
authors.affiliation: Athena Institute, VU University Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Van den Nieuwboer
authors.affiliation: School of Health and Medical Sciences, Örebro University, 701 82 Örebro, Sweden.
authors.forename: R J
authors.initials: RJ
authors.lastname: Brummer
authors.affiliation: Food Microbiology and Biotechnology Digestive System Research Unit, CIBERehd, University Hospital Vall d'Hebron,, 08035 Barcelona, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Guarner
authors.affiliation: Istituto di Microbiologia Università Cattolica S.C.,, Via Emilia Parmense 84, 29122 Piacenza, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Morelli
authors.affiliation: Departments of Pediatrics, Epidemiology and Biostatistics, University of California San Francisco (UCSF), 3333 California Street, #245, San Francisco, CA 94118, USA.
authors.forename: M
authors.initials: M
authors.lastname: Cabana
authors.affiliation: Athena Institute, VU University Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands Department of Viroscience, Erasmus Medical Center, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Claasen
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016867:Immunocompromised Host; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects*; D058616:Synbiotics / Q000009:adverse effects*
keywords: food safety legislation; immunocompromised people; prebiotics; probiotics; synbiotics