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Microorganisms
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Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive...
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Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive Potential Across Diverse Medical Conditions

A special issue of Microorganisms (ISSN 2076-2607). This special issue belongs to the section "Medical Microbiology".

Deadline for manuscript submissions: closed (28 February 2026) | Viewed by 10098

Special Issue Editors

Dr. Francesco Broccolo

E-Mail Website
Guest Editor
Department of Experimental Medicine, University of Salento, Lecce, Italy
Interests: microbiome; probiotics; preventive medicine; artificial intelligence in medicine
Special Issues, Collections and Topics in MDPI journals
Dr. Marcello Romeo

E-Mail Website
Guest Editor
Department of Biology and Biotechnology, University of Pavia, 27100 Pavia, Italy
Interests: probiotics; microbiome

Special Issue Information

Dear Colleagues,

Probiotics have gained increasing attention for their role in and restoration of a healthy microbiota, which is crucial for overall health.

This Special Issue of Microorganisms focuses on the use of probiotics in various clinical settings, with particular attention being paid to their role in the prevention and treatment of diverse diseases, including neuropsychiatric, autoimmune, metabolic, and gastrointestinal disorders.

The selection of probiotic strains is critical, as specific bacterial characteristics and properties must be tailored to address distinct clinical needs.

This Special Issue aims to showcase recent advances in the clinical validation of probiotic formulations and explore how novel probiotic blends can be integrated into therapeutic and preventive practices. By highlighting clinical studies and real-world applications, this issue seeks to provide valuable insights into the potential of probiotics as an adjunct or alternative approach in managing a wide array of medical conditions. 

Dr. Francesco Broccolo
Dr. Marcello Romeo
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Microorganisms is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • probiotics
  • microbiota
  • clinical validation
  • therapeutic applications
  • preventive therapy
  • novel probiotic blends
  • medical conditions
  • specific strains

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Published Papers (4 papers)

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9 pages, 2244 KB  
Communication
Lactococcus lactis Strain Plasma Uniquely Induces IFN-α Production via Plasmacytoid Dendritic Cell Activation: A Comparative Study of Postbiotic Products
by Shigeru Fujimura, Masato Kawamura and Yurina Tamura
Microorganisms 2025, 13(10), 2261; https://doi.org/10.3390/microorganisms13102261 - 26 Sep 2025
Cited by 2 | Viewed by 2889
Abstract
Postbiotics are increasingly incorporated into functional foods and supplements due to their potential health benefits, particularly immune modulation. However, the mechanisms by which these products influence antiviral immunity remain incompletely understood. Type I interferons, especially interferon-α (IFN-α), are central mediators of early antiviral [...] Read more.
Postbiotics are increasingly incorporated into functional foods and supplements due to their potential health benefits, particularly immune modulation. However, the mechanisms by which these products influence antiviral immunity remain incompletely understood. Type I interferons, especially interferon-α (IFN-α), are central mediators of early antiviral defense, acting primarily through the activation of plasmacytoid dendritic cells (pDCs). Five commercially available postbiotic products containing heat-killed bacterial strains were evaluated for their ability to stimulate pDCs and induce IFN-α production. Bacterial uptake by pDCs was analyzed using confocal microscopy with Z-stack imaging, and IFN-α levels were quantified by ELISA. Among the tested strains, only Lactococcus lactis strain Plasma (LC-Plasma) demonstrated significant internalization by pDCs and induced measurable IFN-α production (73.8 ± 2.5 pg/mL) at the recommended daily dose. This effect was not observed with other strains, even at higher bacterial loads (up to 1 × 1011 cells). Z-stack imaging confirmed that LC-Plasma was actively phagocytosed by pDCs, whereas other strains, such as L. paracasei MCC1849, adhered to the cell surface without internalization. The pDC concentration used in the assay approximated physiological levels in human blood. Notably, the IFN-α level induced by LC-Plasma exceeded that reported in the serum of hospitalized COVID-19 patients. L. lactis strain Plasma uniquely activates pDCs and induces IFN-α production under physiologically relevant conditions, distinguishing it from other postbiotic strains. These findings suggest that LC-Plasma may serve as a functional postbiotic with the potential to enhance antiviral immunity and mitigate disease severity. Full article
(This article belongs to the Special Issue Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive Potential Across Diverse Medical Conditions)
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20 pages, 1348 KB  
Commentary
Why Clinical Trials of Microbiome-Targeted Interventions Often Fail to Support Health Claims: A Commentary on Probiotics and Translational Design
by Raul de Jesus Cano and Gissel García Menéndez
Microorganisms 2026, 14(2), 470; https://doi.org/10.3390/microorganisms14020470 - 14 Feb 2026
Cited by 2 | Viewed by 1503
Abstract
The rapid expansion of probiotics and other microbiome-modulating interventions has been accompanied by a growing number of human clinical trials. However, despite frequent reports of statistically significant microbiome changes, relatively few studies generate evidence that convincingly supports health claims or translates into reproducible, [...] Read more.
The rapid expansion of probiotics and other microbiome-modulating interventions has been accompanied by a growing number of human clinical trials. However, despite frequent reports of statistically significant microbiome changes, relatively few studies generate evidence that convincingly supports health claims or translates into reproducible, clinically meaningful outcomes. This gap is often attributed to the inherent complexity and inter-individual variability of the gut microbiome; however, recurring shortcomings in trial design and interpretation likely play an equally important role. In this Commentary, we examine common failure modes that weaken the clinical validation of microbiome-mediated interventions. These include overreliance on descriptive microbiome metrics (e.g., alpha diversity and taxonomic shifts) as surrogate endpoints, misalignment between prespecified endpoints and the claims ultimately advanced, and excessive dependence on symptom-only outcomes in settings characterized by substantial placebo responsiveness. We further highlight how inadequate control of key confounders—particularly diet, antibiotic exposure, and concomitant medications—combined with endpoint overload and underpowered study designs, can obscure true biological signal and increase the risk of irreproducible findings. We argue that stronger evidence emerges when the microbiome is treated as a mechanistic mediator rather than a clinical endpoint. Trials are most interpretable when intended claims are prospectively defined, linked to explicit biological mechanisms, and evaluated using a hierarchy of endpoints that prioritizes host-relevant outcomes and objective biomarkers, with microbiome measures integrated to support mechanistic plausibility. Adoption of staged development pathways disciplined statistical planning, and transparent management of confounding variables can further improve reproducibility and clinical relevance. Full article
(This article belongs to the Special Issue Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive Potential Across Diverse Medical Conditions)
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23 pages, 1371 KB  
Systematic Review
Probiotics for Anxiety and Depressive Symptoms in Cancer: A Systematic Review of Animal and Human Studies with Mechanistic Insights
by Zahra Amirkhanzadeh Barandouzi, Deborah Watkins Bruner, Yufen Lin, Hannah Choi, Layla R. Zeki, Tobi Akangbe, Amruta Epari and Hongjin Li
Microorganisms 2026, 14(1), 51; https://doi.org/10.3390/microorganisms14010051 - 25 Dec 2025
Viewed by 823
Abstract
Probiotics have been increasingly evaluated for their potential effect on anxiety and depression through the modulation of the gut–brain axis. Individuals with cancer experience a high prevalence of these symptoms. However, the effects of probiotics and their underlying mechanisms in this population have [...] Read more.
Probiotics have been increasingly evaluated for their potential effect on anxiety and depression through the modulation of the gut–brain axis. Individuals with cancer experience a high prevalence of these symptoms. However, the effects of probiotics and their underlying mechanisms in this population have not been systematically evaluated. This review synthesizes current evidence regarding probiotic interventions for anxiety and depression in cancer and examines the associated mechanistic pathways. A systematic search for original trials in PubMed, Embase, CINAHL, Web of Science, and PsycINFO was conducted in May 2025. Eligible studies included animal models or adults with cancer who received probiotics alone or in combination with other treatments, with outcomes related to anxiety, depressive symptoms, or depression. Search terms included animal model, cancer, probiotics, anxiety, depressive symptoms, depression, gastrointestinal microbiome, gut microbiome, and microbiota. The review followed PRISMA guidelines. Risk of bias in trials was assessed using the SYRCLE and Cochrane RoB2 tool. Nine studies met the inclusion criteria, including seven human studies, one animal study, and one mixed human–animal study, with human sample sizes ranging from 24 to 266. The animal study reported reductions in depressive and anxiety-like behaviors, paralleled by modulation of the hypothalamic–pituitary–adrenal (HPA) axis, reduced inflammation, rebalancing of the gut microbiota, and improvements in neurotransmitter pathways. Findings from human studies were more variable. Some trials reported improvements in anxiety, and depressive symptoms, while others showed no significant differences compared with control groups. Studies that combined probiotics with antidepressants or exercise demonstrated the most pronounced reductions in anxiety and depression. Mechanistic insights from human studies partially aligned with animal evidence, with several trials showing reductions in inflammatory markers (IL-6, TNF-α), improvements in neuroendocrine measures (serotonin, dopamine, cortisol), stabilization of metabolic markers, and favorable shifts in gut microbiota, although these effects were not consistent across all studies. Probiotics appear to be safe within the intervention periods of the reviewed studies (<24 weeks), as no serious adverse effects were reported. Substantial heterogeneity across studies, including variations in cancer type, intervention duration, probiotic strains, formulations, dosages, and study design combined with small sample sizes, restricts the ability to draw definitive conclusions. Rigorously designed randomized controlled trials with larger sample sizes and mechanistic biomarkers are required to confirm the efficacy of probiotics for relieving anxiety and depression in the cancer population. Full article
(This article belongs to the Special Issue Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive Potential Across Diverse Medical Conditions)
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17 pages, 1129 KB  
Systematic Review
The Potential of Probiotics in Reducing Ventilator-Associated Pneumonia: A Literature-Based Analysis
by Tao-An Chen, Ya-Ting Chuang, Szu-Chi Pai and Jin-Fu Zheng
Microorganisms 2025, 13(4), 856; https://doi.org/10.3390/microorganisms13040856 - 9 Apr 2025
Cited by 1 | Viewed by 3815
Abstract
Ventilator-associated pneumonia (VAP) remains a significant concern in intensive care units (ICUs), contributing to increased morbidity, mortality, and healthcare costs. Probiotics and synbiotics have been explored as potential preventive measures due to their ability to modulate gut microbiota, reduce pathogenic colonization, enhance immune [...] Read more.
Ventilator-associated pneumonia (VAP) remains a significant concern in intensive care units (ICUs), contributing to increased morbidity, mortality, and healthcare costs. Probiotics and synbiotics have been explored as potential preventive measures due to their ability to modulate gut microbiota, reduce pathogenic colonization, enhance immune responses, and maintain intestinal barrier integrity. While some randomized controlled trials (RCTs) suggest that specific strains, such as Lactobacillus rhamnosus GG and Bifidobacterium breve, may reduce VAP incidence, larger trials have not confirmed significant benefits. Systematic reviews and meta-analyses indicate a potential 28–38% relative risk reduction in VAP, but evidence quality remains low due to methodological limitations and study heterogeneity. Economic evaluations also question the cost effectiveness of probiotic use in ICU settings. Future research should focus on large-scale, multicenter RCTs to determine the optimal strains, dosages, and administration methods, along with standardized diagnostic criteria. Until stronger evidence emerges, probiotics should be considered an adjunctive rather than a primary VAP prevention strategy. Full article
(This article belongs to the Special Issue Clinical Applications and Validation of Probiotics: Exploring Therapeutic and Preventive Potential Across Diverse Medical Conditions)
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