Safety of probiotics and synbiotics in children under 18 years of age
Open accessAbstract
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.
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- Authors
- van den Nieuwboer, M., Brummer, R. J., Guarner, F., Morelli, L., Cabana, M., & Claassen, E.
- Affiliations
- VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands
- Örebro University (SE)
- Vall d'Hebron Hospital Universitari (ES)
- Università Cattolica del Sacro Cuore (IT)
- University of California, San Francisco (US)
- Erasmus MC (NL)
- Venue
- Beneficial Microbes
- Publisher
- Walter de Gruyter GmbH
- Published
- 2015-10-15
- Volume
- 6
- Issue
- 5
- Pages
- 615-630
- ISSN
- 1876-2883 (ISSN-L)
- 1876-2891
- OpenAlex
- W2075624961
- Cited by
- 83
- References
- 114
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 2 · 2023: 8 · 2022: 16 · 2021: 5 · 2020: 6 · 2019: 11 · 2018: 7 · 2017: 9 · 2016: 7 · 2015: 4
- FWCI
- 12.04
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Beneficial Microbes (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- VU Research Portal (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- probiotics, synbiotics, safety, children, adverse events, CTCAE, probiotic strains, adverse event reporting, obese children, intestinal disorders, inflammatory diseases
- MeSH terms
- Adolescent, Child, Child, Preschool, Humans, Infant, Infant, Newborn, Probiotics, Synbiotics, Drug-Related Side Effects and Adverse Reactions
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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