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].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [220]
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“Although probiotic supplementation has earlier been associated with higher risks of sepsis and fungemia in critically ill patients [68], it was only recently shown that probiotics supplementation in pediatric ICU patients could result in the systemic translocation of probiotic bacteria.”
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“Here, Lactobacillus species were identified as promising probiotics to ameliorate MASLD due to their beneficial effects on lipid and bile acid metabolism, inflammation and intestinal barrier function.”
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“Furthermore, in critically ill or immunocompromised patients, probiotic administration was associated with a higher infection risk and mortality, mainly due to sepsis or fungemia [126,127].”
BackgroundProbiotics in Dermatology: An Evidence-based Approach
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“…strains of S. cerevisiae act as food spoilage organisms, exhibiting undesirable qualities, for example, in olives or cheese (20), and some strains are opportunistic human pathogens (21) or probiotics in the case of S. cerevisiae var. boulardii, the most common commercial human probiotic yeast (22).”
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“Additional reports showed that long term probiotic use interferes with the gut commensal bacteria and may result in sepsis, fungemia and GI ischemia (55).”
BackgroundLee, M., Bang, W.-Y., Lee, H.-B., Yang, S., Lee, K., Kang, H., Hong, S. M., & Yang, J. (2024) · Microorganisms · doi:10.3390/microorganisms12102063 · Cited by 16
“These are mostly manifested in young children and very low birth weight infants; seriously ill adults and infants in intensive care units; and postoperative, hospitalized, or immuno-compromised patients, in part due to bacteremia and fungemia [10].”
BackgroundProbiotic and enterohemorrhagic Escherichia coli: An effective strategy against a deadly enemy?
Cordonnier, C., Thévenot, J., Etienne‐Mesmin, L., Alric, M., Livrelli, V., & Blanquet‐Diot, S. (2016) · Critical Reviews in Microbiology · doi:10.1080/1040841x.2016.1185602 · Cited by 17
“Even if probiotics are well-recognized for their health beneficial effects in human, probiotic therapy can be contraindicated, mainly in critically ill patients, critically sick infants, postoperative as well as in hospitalized and immune-compromised patients (Didari et al., 2014; Snydman, 2008).”
BackgroundGu, J., Song, K., Fan, Y., Dong, Y., Qian, L., & Gai, Z. (2024) · Microbial Pathogenesis · doi:10.1016/j.micpath.2024.106809 · Cited by 15
Oral microbiota and respiratory diseases: advances and perspectives
Liu, X., Shi, F., Zeng, J., Bi, J., Mo, C., Chai, Y., Wu, B., & Xu, S. (2025) · Clinical Microbiology Reviews · doi:10.1128/cmr.00150-24 · Cited by 20
Therapeutic implications of the gastrointestinal microbiome
Kashyap, P., & Quigley, E. M. M. (2018) · Current Opinion in Pharmacology · doi:10.1016/j.coph.2018.01.004 · Cited by 15
Janket, S., Ackerson, L. K., & Diamandis, E. P. (2019) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2019-0605 · Cited by 14
“Thus, the logical next course of research seems to be conducting longitudinal studies controlling for all relevant confounding factors before exposing immune-suppressed cancer patients to potential harm from supplementation of live bacteria [73] or fecal transplantation [74].”
BackgroundA New Therapy for Uncomplicated Vulvovaginal Candidiasis and Its Impact on Vaginal Flora
Stabile, G., Gentile, R. M., Carlucci, S., Restaino, S., & De Seta, F. (2021) · Healthcare · doi:10.3390/healthcare9111555 · Cited by 13
“Still, the risk of adverse effects usually interests critically ill patients in intensive care units, critically sick infants, postoperative and hospitalized patients, and patients with immunocompromised complexity [17].”
BackgroundModulation of the gut microbiota: opportunities and regulatory aspects
Ribaldone, D. G., Pellicano, R., Fagoonee, S., & Actis, G. C. (2022) · Minerva Gastroenterology · doi:10.23736/s2724-5985.22.03152-7 · Cited by 13
Türkiye'deki Eczanelerde Bulunan Probiyotiklere Genel Bakış
Korkut, O., & Şen, F. (2022) · Balıkesır Health Sciences Journal · doi:10.53424/balikesirsbd.1115356 · Cited by 13
Treating asthma patients with probiotics: a systematic review and meta-analysis
Wang, Y., Xie, Q., & Yuan, J. (2023) · Nutrición Hospitalaria · doi:10.20960/nh.04360 · Cited by 13
Paliy, А., Gujvinska, S. O., Лівощенко, Л. П., Nalivayko, L. I., Livoshchenko, Y. M., Risovaniy, V. I., Анатольевич, Д. Р., Berezhna, N. V., Palii, А. P., & Петров, Р. В. (2020) · Ukrainian Journal of Ecology · doi:10.15421/2020_7 · Cited by 13
“The search for strains of microorganisms that have the properties of the vitamins synthesis, amino acids, enzymes, antibiotic substances, is crucial in the development of innovative probiotic drugs and requires methodologically correct research using modern methods (Toomy et al., 2010; Didari et al., 2014; Gujvinska e…”
MethodSafety Evaluation of a Novel Potentially Probiotic Limosilactobacillus fermentum in Rats
Neto, J. P. R. C., de Oliveira, A. M., de Oliveira, K. Á. R., Sampaio, K. B., Dutra, M. L. D. V., Freire, M. O. D. L., de Souza, E. L., & Alves, J. L. D. B. (2023) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-023-10077-3 · Cited by 13
“However, there is a paucity of studies investigating the safety or adverse effects of probiotics [35].”
Peña, F., Mizgier, M. L., Morales, P., Rios, I., Carrasco‐Pozo, C., Díaz-Bautista, E., Brunser, O., & Gotteland, M. (2014) · Journal of Food and Nutrition Research · doi:10.12691/jfnr-2-8-10 · Cited by 14
“Bifidobacterium is a normal member of the human resident gut microbiota; it is considered as a safe microorganism and is widely consumed in the world though some caution must be considered when administered to critically ill patients or strongly immunosupressed subjects [31].”
BackgroundKıran, F., Sevin, S., & Ceylan, A. (2022) · Veterinary Research Communications · doi:10.1007/s11259-022-10036-3 · Cited by 12
“However, not all lactic acid bacteria are identified as GRAS which makes it necessary to evaluate the safety criteria of each potential strain (Didari et al. 2014; Plavec and Berlec, 2020).”
BackgroundLeveraging the microbiome in the treatment of sepsis: potential pitfalls and new perspectives
Biemond, J. J., McDonald, B., & Haak, B. W. (2023) · Current Opinion in Critical Care · doi:10.1097/mcc.0000000000001019 · Cited by 12
“Not only do these agents appear to be of no clinical benefit, they sometimes even appear to harm critically ill patients [11].”
BackgroundJung, S., Cho, K., Jung, E.-S., Son, D., Byun, J.-S., Kim, S.-I., Chae, S., Yang, J.-C., Lee, S., & Lim, S. (2025) · Nutrients · doi:10.3390/nu17040691 · Cited by 17
Exploring the Role of Gut Microbiota and Probiotics in Acute Pancreatitis: A Comprehensive Review
Nista, E. C., Parello, S., Brigida, M., Amadei, G. A., Saviano, A., Lucia, S. S. D., Petruzziello, C., Migneco, A., & Ojetti, V. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26073433 · Cited by 15
“Concerning FMT, most of the issues in standardization are related to donor selection and screening.”
The Role of Probiotics in Modulating the Gut Microbiome in Alzheimer’s Disease: A Review
Dong, Y., Wu, X., Zhang, Y., Hu, A., Zhou, Q., Yue, X., Liu, Z., & Li, M. (2025) · Foods · doi:10.3390/foods14091531 · Cited by 15
“Currently, the most widely used probiotics are Lactobacillus and Bifidobacterium , which have been declared safe and beneficial to the human body [112].”
Rare Yeast Infections: Risk Factors, Clinical Manifestations, Treatment, and Special Considerations
Byrne, D. D., & Reboli, A. C. (2017) · Current Clinical Microbiology Reports · doi:10.1007/s40588-017-0073-7 · Cited by 12
Khodadoostan, M., Shavakhi, A., Sherafat, Z., & Shavakhi, A. (2018) · Advanced Biomedical Research · doi:10.4103/abr.abr_216_17 · Cited by 12
“[16] Various studies have examined the beneficial effect of probiotics in gut microbiota,[17,18] but no study has evaluated the impact of using of probiotics initiated at different times after the colonoscopy.”
Liu, Q., Bian, Y., Mu, S., Chen, M., Liu, S., Yang, G., Huang, Y., Hou, X., & Fang, Y. (2023) · Genomics · doi:10.1016/j.ygeno.2023.110724 · Cited by 12
Bennett, W. E. (2015) · Drug Safety · doi:10.1007/s40264-015-0349-x · Cited by 12
“[23] focused on the risk of probiotics across all settings, and found that probiotics were generally safe, but found increased risk for immunocompromised patients, critically ill patients, and those at the extremes of age.”
BackgroundChang, C., & Pan, T. (2019) · Food & Function · doi:10.1039/c9fo01819k · Cited by 12
Ruiz, M. J., Zbrun, M. V., Signorini, M. L., Zimmermann, J. A., Soto, L. P., Rosmini, M. R., & Frizzo, L. S. (2021) · Archives of Microbiology · doi:10.1007/s00203-021-02385-5 · Cited by 12
Fatahi, S., Hosseini, A., Sohouli, M. H., Sayyari, A., Khatami, K., Farsani, Z. F., Amiri, H., Dara, N., de Souza, I. G. O., & Santos, H. O. (2022) · World Journal of Pediatrics · doi:10.1007/s12519-022-00516-6 · Cited by 13
“rhamnosus) and Saccharomyces boulardii [57].”
Lee, Y., Cho, H., & Kim, K.-S. (2025) · Journal of Drug Delivery Science and Technology · doi:10.1016/j.jddst.2025.106607 · Cited by 12
Ribeiro, A. G., Rabello, C. B.-V., dos Santos, M. J. B., Nascimento, J. C. D. S., da Silva, D. A., Oliveira, H. S. D. H., Macambira, G. M., dos Santos, A. C. F., Maciel, M. D. S., Carvalho, C. B. D. M., et al. (2021) · Research Society and Development · doi:10.33448/rsd-v10i10.18800 · Cited by 11
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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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