The DOI matches its Crossref record; 117 of the 117 references it cites were found in a registry or an index.
A systematic review of the safety of probiotics
Abstract
INTRODUCTION: There is growing evidence on the use of probiotics in various diseases, especially in gastrointestinal (GI) diseases. Although probiotics have been found helpful in many illnesses, they do not always seem to be safe. Through interference with commensal microflora, they can result in opportunistic performances in the host due to bacterimia and fungemia. Since considerable numbers of consumers use probiotic products worldwide, assurance of safety of these products is necessary. AREAS COVERED: This review evaluates all the existing information about the safety of probiotics in humans and animal models up to May 2013. In all eligible published studies in which adverse effects and tolerability of probiotics were investigated and reported, no language limitations were applied. The main key search terms were 'probiotics,' 'safety,' 'side effects,' 'clinical trial' and 'adverse effects.' The vast majority of trials investigated Bifidobacterium (B) and Lactobacillus (L) species. EXPERT OPINION: The main observed adverse effects of probiotics were sepsis, fungemia and GI ischemia. Generally, critically ill patients in intensive care units, critically sick infants, postoperative and hospitalized patients and patients with immune-compromised complexity were the most at-risk populations. While the overwhelming existing evidence suggests that probiotics are safe, complete consideration of risk-benefit ratio before prescribing is recommended.
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“A systematic literature review of probiotic safety published in 2014 reported that “the overwhelming existing evidence suggests that probiotics are safe” for the general population, and that critically ill patients, postoperative and hospitalized patients and immunocompromised patients were the most at-risk groups wherein AEs occurred [220].”
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“Nevertheless, side effects such as systemic infections, mild gastrointestinal disturbances and skin complications have been reported [5,10].”
BackgroundA cell-free, biomimetic hydrogel based on probiotic membrane vesicles ameliorates wound healing
Kuhn, T., Aljohmani, A., Frank, N. A., Zielke, L., Mehanny, M., Laschke, M. W., Koch, M., Hoppstädter, J., Kiemer, A. K., Yildiz, D., et al. (2023) · Journal of Controlled Release · doi:10.1016/j.jconrel.2023.12.011 · Cited by 57
Immunosuppression and probiotics: are they effective and safe?
Stadlbauer, V. (2015) · Beneficial Microbes · doi:10.3920/bm2015.0065 · Cited by 56
Invasive Infections Associated with the Use of Probiotics in Children: A Systematic Review
D’Agostin, M., Squillaci, D., Lazzerini, M., Barbi, E., Wijers, L., & Lozzo, P. D. (2021) · Children · doi:10.3390/children8100924 · Cited by 60
“However, only a few systematic safety studies have been carried out, particularly in vulnerable populations, and most of the existing published studies on probiotics have not specifically reported safety, leaving uncertainties regarding their potential risks [15,16].”
BackgroundBekiaridou, Α., Karlafti, E., Oikonomou, I. M., Ioannidis, A., & Papavramidis, T. S. (2021) · Nutrients · doi:10.3390/nu13124265 · Cited by 55
“Theoretical risks that include systemic infections and excessive immune response have been described without observational data [45,46].”
BackgroundProbiotics and postbiotics play a role in maintaining dermal health
Rawal, S., & Ali, S. A. (2023) · Food & Function · doi:10.1039/d3fo00152k · Cited by 60
Alam, Z., Shang, X., Effat, K., Kanwal, F., He, X., Li, Y., Xu, C., Niu, W., War, A. R., & Zhang, Y. (2022) · Journal of Food Biochemistry · doi:10.1111/jfbc.14302 · Cited by 53
Awuchi, C. G., & Okpala, C. O. R. (2022) · Journal of Food Bioactives · doi:10.31665/jfb.2022.18317 · Cited by 59
Value of Probiotics in Canine and Feline Gastroenterology
Schmitz, S. S. (2020) · Veterinary Clinics of North America Small Animal Practice · doi:10.1016/j.cvsm.2020.09.011 · Cited by 52
Zhang, L., Xu, J.-Y., Xing, Y., Wu, P., Jin, Y.-W., Wei, W., Zhao, L., Yang, J., Chen, G., & Qin, L. (2024) · Microbiological Research · doi:10.1016/j.micres.2024.127821 · Cited by 53
Chen, Y., Qi, A., Teng, D., Li, S., Yan, Y., Hu, S., & Du, X. (2022) · Techniques in Coloproctology · doi:10.1007/s10151-022-02585-1 · Cited by 49
“Therefore, probiotics and synbiotics should be used in consideration of their possible side effects, which need to be confirmed by more studies [38].”
BackgroundNutraceuticals as modulators of gut microbiota: Role in therapy
Quigley, E. M. M. (2019) · British Journal of Pharmacology · doi:10.1111/bph.14902 · Cited by 47
Probiotics in obstetrics and gynaecology
Griffin, C. J. (2015) · Australian and New Zealand Journal of Obstetrics and Gynaecology · doi:10.1111/ajo.12303 · Cited by 47
Saccharomyces cerevisiae fungemia after probiotic treatment in an intensive care unit patient
Kara, İ., Yıldırım, F., ., O. O., Erganiş, S., Aydoğdu, M., Dizbay, M., Gürsel, G., & Kalkancı, A. (2017) · Journal de Mycologie Médicale · doi:10.1016/j.mycmed.2017.09.003 · Cited by 46
Garg, V., Velumani, D., Lin, Y.-C., & Haye, A. (2024) · PharmaNutrition · doi:10.1016/j.phanu.2024.100423 · Cited by 44
A Brief Overview on Probiotics: The Health Friendly Microbes
Mishra, S., & Acharya, S. (2021) · Biomedical & Pharmacology Journal · doi:10.13005/bpj/2285 · Cited by 48
Probiotics and their applications in functional foods: a health perspective
Amin, M. R., Biswas, A. P., Tasnim, M., Islam, M. N., & Azam, M. S. (2025) · Applied Food Research · doi:10.1016/j.afres.2025.101193 · Cited by 48
Gut Microbiome and Common Variable Immunodeficiency: Few Certainties and Many Outstanding Questions
Varricchi, G., Poto, R., Ianiro, G., Punziano, A., Marone, G., Gasbarrini, A., & Spadaro, G. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.712915 · Cited by 45
“Finally, synbiotics themselves can be associated with adverse events and their safety profile is often overlooked (205, 206).”
BackgroundDealing with the remaining controversies of probiotic safety
van den Nieuwboer, M., & Claassen, E. (2019) · Beneficial Microbes · doi:10.3920/bm2018.0159 · Cited by 41
Probiotic-Associated Aspiration Pneumonia Due to Lactobacillus rhamnosus
Doern, C. D., Nguyen, S. T., Afolabi, F., & Burnham, C.-A. D. (2014) · Journal of Clinical Microbiology · doi:10.1128/jcm.01065-14 · Cited by 41
“Lactobacilli are low-virulence organisms that are commensals of the genitourinary and gastrointestinal tracts and are commonly used as probiotic supplements (15).”
BackgroundAntibiotics and probiotics in inflammatory bowel disease: when to use them?
Abraham, B. P., & Quigley, E. M. M. (2019) · Frontline Gastroenterology · doi:10.1136/flgastro-2018-101057 · Cited by 39
“62 63 Since probiotic strains typically do not colonise the adult colon and repeated or indefinite use is required for an ongoing effect, long-term maintenance studies in IBD are needed.”
The potential role of interventions impacting on gut-microbiota in epilepsy
Iannone, L. F., Gómez-Eguílaz, M., Citaro, R., & Russo, E. (2020) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2020.1759414 · Cited by 38
Probiotics and human lactational mastitis: A scoping review
Barker, M., Adelson, P., Peters, M. D. J., & Steen, M. (2020) · Women and Birth · doi:10.1016/j.wombi.2020.01.001 · Cited by 36
Gut Microbiota Modulation: Implications for Infection Control and Antimicrobial Stewardship
Tan, G. S. E., Tay, H. L., Tan, S. H., Lee, T. H., Ng, T. M., & Lye, D. C. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01458-z · Cited by 38
Altered gut microbiome associated with overactive bladder and daily urinary urgency
Okamoto, T., Hatakeyama, S., Imai, A., Yamamoto, H., Yoneyama, T., Mori, K., Yoneyama, T., Hashimoto, Y., Nakaji, S., & Οhyama, C. (2020) · World Journal of Urology · doi:10.1007/s00345-020-03243-7 · Cited by 34
“Some bacteria of the genus Bifidobacterium may play critical beneficial roles and have been used as probiotics [28, 29].”
BackgroundProbiotics in health and disease: fooling Mother Nature?
Abid, M. B., & Koh, C. J. (2019) · Infection · doi:10.1007/s15010-019-01351-0 · Cited by 37
Catho, G., & Huttner, B. D. (2019) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2019.1645007 · Cited by 33
“So far there is no evidence for the impact of probiotics on decolonization and caution should be taken before applying probiotics for this purpose in routine clinical practice, since manipulation of the microbiome could lead to unintended consequences and probiotics may also be the cause of infections, particularly in…”
BackgroundStrategies for the Development of Bioprotective Cultures in Food Preservation
Souza, L. V., Martins, E., Moreira, I. M. F. B., & de Carvalho, A. F. (2022) · International Journal of Microbiology · doi:10.1155/2022/6264170 · Cited by 41
Rousseau, A., & Martindale, R. G. (2024) · Annals of Intensive Care · doi:10.1186/s13613-024-01350-x · Cited by 36
“Due to their immunocompromised status, critically ill patients are at risk of bacteremia or fungemia secondary to probiotics administration [113].”
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Self-citationDinić, M., Burgess, J. L., Lukić, J., Catanuto, P., Radojević, D., Marjanović, J., Verpile, R., Thaller, S. R., Gonzalez, T., Golić, N., et al. (2024) · The FASEB Journal · doi:10.1096/fj.202400054rr · Cited by 35
“9,10 Commercially available probiotics can have a different ratio of living and dead bacterial cells, depending on the methods of formulation, which can affect biological effect after application.”
Metadata
- Authors
- Didari, T., Solki, S., Mozaffari, S., Nikfar, S., & Abdollahi, M.
- Affiliations
- Islamic Azad University, Tehran (IR)
- Pharmaceutical Sciences Research Center (IR)
- Ministry of Health and Medical Education (IR)
- Venue
- Expert Opinion on Drug Safety
- Publisher
- Informa Healthcare
- Published
- 2014-01-03
- Volume
- 13
- Issue
- 2
- Pages
- 227-239
- ISSN
- 1474-0338 (ISSN-L)
- 1744-764X
- OpenAlex
- W2125631968
- Cited by
- 367
- References
- 117
- Citations by year
- 2026: 27 · 2025: 44 · 2024: 32 · 2023: 42 · 2022: 41 · 2021: 41 · 2020: 38 · 2019: 28 · 2018: 27 · 2017: 14 · 2016: 11 · 2015: 14 · 2014: 8
- FWCI
- 1.94
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Expert Opinion on Drug Safety (publishedVersion)
- PubMed (publishedVersion)
- 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
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- probiotics, probiotic safety, adverse effects, sepsis, fungemia, gastrointestinal ischemia, Bifidobacterium, Lactobacillus, opportunistic infections, commensal microbiota, critically ill patients, immunocompromised patients, risk-benefit ratio
- MeSH terms
- Animals, Bifidobacterium, Humans, Lactobacillus, Safety, Probiotics, Drug-Related Side Effects and Adverse Reactions
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