Safety assessment of probiotics for human use
Open accessAbstract
The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods.
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Use of AI to analyze big data for real-time monitoring will simplify clinical trials by providing monitoring of adverse events and more accurate tracking of specific strains in real time.
“The use of AI to analyze big data for real-time monitoring will simplify clinical trials by providing monitoring of adverse events and more accurate tracking of specific strains in real time to evaluate a more complete safety profile of probiotics [19].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [19]
The Introduction and Scope (page unavailable) says human studies have tracked adverse incidents and that improved methods have helped trace incidents to specific probiotic strains. The Microbiological and Metabolic Issues Related to Safety section (page unavailable) also describes strain identification as important for tracking and safety surveillance. Neither passage supports the claim that AI analysis of big data enables real-time monitoring or simplifies clinical trials. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIntestinal barrier dysfunction may contribute to infection development, which can subsequently lead to sepsis or inflammation.
“In such vulnerable patient groups, intestinal barrier dysfunction increases the risk of adverse effects from probiotics [81] and may contribute to infection development, which can subsequently lead to sepsis or inflammation [19].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [19]
Probiotic safety is linked to intended use, strain identity, and historical evidence of safe exposure, and is distinct from classical pathogenic risk assessment.
“Consistent with established guidance, probiotic safety is linked to intended use, strain identity, and historical evidence of safe exposure, and is distinct from classical pathogenic risk assessment.20-22”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [21]
Recommended safety criteria in selecting probiotics include isolation environment, taxonomic identification, and absence of virulence and transferable antibiotic resistance genes.
“Recommended safety criteria in selecting probiotics include isolation environment, taxonomic identification, and absence of virulence and transferable antibiotic resistance genes [13].”
From Probiotic and Antifungal Attributes of Lactic Acid Bacteria Isolates from Naturally Fermented Brazilian Table Olives (2022) · cites this paper as [13]
Overall, probiotics have an excellent safety profile with a large majority of clinical trials involving probiotics not giving rise to major safety concerns.
“Overall, probiotics have an excellent safety profile with a large majority of clinical trials involving probiotics not giving rise to major safety concerns [213].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [213]
Probiotics have been studied in vulnerable groups including infants, patients with severe acute pancreatitis, inflammatory bowel diseases, liver diseases, HIV, and other conditions, with greater cause for concern for products containing high concentrations up to 450-900 billion live bacteria per dose.
“Further, probiotics have been studied in vulnerable groups, including infants, patients with severe acute pancreatitis, inflammatory bowel diseases, liver diseases, HIV, and other conditions [213, 216–218] with even greater cause for concern with the small number of products that contain high concentrations of up to 450–900 billion live bacteria per dose [211].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [213]
Immunocompromised hosts might be at higher risk for adverse events from probiotics due to their reduced ability to defend against a microbial challenge.
“Although beneficial effects of probiotics in such groups are reported, immunocompromised hosts might be at higher risk for AEs due to their reduced ability to defend against a microbial challenge.104”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [104]
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- Authors
- Sanders, M. E., Akkermans, L. M. A., Haller, D., Hammerman, C., Heimbach, J. T., Hörmannsperger, G., & Huys, G.
- Affiliations
- University Medical Center Utrecht (NL)
- Technical University of Munich (DE)
- Shaare Zedek Medical Center (IL)
- Ludwig-Maximilians-Universität München (DE)
- Ghent University (BE)
- Corresponding author
- Sanders, Mary Ellen
- Venue
- Gut Microbes
- Publisher
- Informa UK Limited
- Published
- 2010-05
- Volume
- 1
- Issue
- 3
- Pages
- 164-185
- ISSN
- 1949-0976 (ISSN-L)
- 1949-0984
- PMC
- PMC3023597
- OpenAlex
- W2019795434
- Cited by
- 816
- References
- 201
- Citations by year
- 2026: 89 · 2025: 87 · 2024: 93 · 2023: 69 · 2022: 70 · 2021: 74 · 2020: 56 · 2019: 41 · 2018: 56 · 2017: 36 · 2016: 26 · 2015: 25 · 2014: 27 · 2013: 28 · 2012: 20
- FWCI
- 2.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- Gut Microbes (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Keywords
- probiotic safety, probiotic safety assessment, antibiotic resistance genes, genetic stability, pathogenicity, immunological effects, infants, mode of administration, gut microbiota, toxin production, vulnerable populations
- MeSH terms
- Animals, Bacteria, Consumer Product Safety, Drug Therapy, Humans, Intestines, Randomized Controlled Trials as Topic, Probiotics, Food Safety
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