Ultra-processed foods (UPFs) have become a widely consumed food category in modern diets. However, their impact on gut health is raising increasing concerns. This review investigates how UPFs impact the gut microbiome and gut barrier, emphasizing gut dysbiosis and increased gut permeability. UPFs, characterized by a high content of synthetic additives and emulsifiers, and low fiber content, are associated with a decrease in microbial diversity, lower levels of beneficial bacteria like Akkermansia muciniphila and Faecalibacterium prausnitzii, and an increase in pro-inflammatory microorganisms. These alterations in the microbial community contribute to persistent inflammation, which is associated with various chronic disorders including metabolic syndrome, irritable bowel syndrome, type 2 diabetes, and colorectal cancer. In addition, UPFs may alter the gut–brain axis, potentially affecting cognitive function and mental health. Dietary modifications incorporating fiber, fermented foods, and probiotics can help mitigate the effects of UPFs. Furthermore, the public needs stricter regulations for banning UPFs, along with well-defined food labels. Further studies are necessary to elucidate the mechanisms connecting UPFs to gut dysbiosis and systemic illnesses, thereby informing evidence-based dietary guidelines.

Background: Titanium dioxide (TiO₂) is used as a food additive in pastries, sweets, and sauces. It is recognized as safe by food safety authorities, but in recent years, governments and scientists have raised concerns about its genotoxicity. This systematic review aims to assess the potential associations between food TiO₂ exposure and microbiota composition and functions. Methods: A systematic literature search was performed up to December 2020 in PubMed, Web of Science, and Scopus databases. The PRISMA guidelines followed. The risk of bias was assessed from ARRIVE and SYRCLE tools. Results: A total of 18 animal studies were included (n = 10 mice, n = 5 rats, n = 2 fruit flies, n = 1 silkworm). Studies varied significantly in protocols and outcomes assessment. TiO₂ exposure might cause variations in abundance in specific bacterial species and lead to gut dysfunctions such as a reduction in SCFAs levels, goblet cells and crypts, mucus production, and increased biomarkers of intestinal inflammation. Conclusions: Although the extrapolation of these results from animals to humans remains difficult, this review highlights the key role of gut microbiota in gut nanotoxicology and stimulates discussions on the safe TiO₂ use in food and dietary supplements. This systematic review was registered at PROSPERO as CRD42020223968.

Background/Objectives: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. Methods: A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. Results: From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. Conclusions: CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.

This scoping review aims to map the existing literature on nutritional knowledge among people with IBD, identify gaps in current understanding, and provide guidance for future educational interventions. Background: Inflammatory bowel diseases (IBDs) are chronic conditions affecting the gastrointestinal tract, where nutrition plays a crucial role in symptom management. Despite its significance, patient knowledge about proper dietary practices remains limited, with widespread misconceptions potentially leading to suboptimal health outcomes. Methods: This review followed the Arksey and O’Malley framework and adhered to PRISMA 2020 guidelines. A systematic search was conducted in three databases (PubMed, Web of Science, and SCOPUS) for studies published between 2003 and 2024. Only studies involving adults (≥18 years) with IBD and focusing on nutritional knowledge were included. Results: From 1440 records initially identified, 23 studies met the inclusion criteria. The findings highlight that IBD patients often base dietary decisions on personal beliefs rather than evidence-based guidelines, leading to widespread food avoidance and increased risk of malnutrition. Misconceptions such as avoiding dairy, gluten, and fiber without professional advice were prevalent. Educational interventions, including personalized counseling and group sessions, showed the potential to improve nutritional knowledge and symptom management, though their application remains inconsistent across settings. Conclusions: IBD patients face significant gaps in nutritional knowledge, emphasizing the need for structured educational initiatives. A personalized, multidisciplinary approach, integrating dietary education into standard care, is essential to improve symptom control and enhance quality of life. Future research should focus on developing evidence-based interventions tailored to the unique needs of this population.

Background: Artificial sweeteners, widely used as non-nutritive sugar substitutes, are increasingly prevalent in ultra-processed products. Although promoted for weight management due to their minimal caloric content, their impact on systemic inflammation remains uncertain. This systematic review of animal studies aims to evaluate the association between artificial sweetener consumption and inflammatory biomarkers. Methods: A systematic literature search was conducted up to May 2025 across PubMed, Web of Science, and Scopus, following PRISMA guidelines and registered in PROSPERO (CRD420251084004). Risk of bias was assessed using the ARRIVE guidelines and SCYRCLE’s risk of bias tool. Results: Thirty-seven animal studies were included: aspartame (n = 17), sucralose (n = 16), acesulfame potassium (n = 5), and saccharin (n = 4). Protocols varied in terms of dosage, exposure duration, animal models, and assessment of inflammatory outcomes, including C-reactive protein, interleukins (IL-6 and IL-1β), and tumor necrosis factor alpha. Aspartame and sucralose could elevate inflammatory markers, with sucralose also disrupting gut integrity and microbiota. Acesulfame K and saccharin showed variable, dose-dependent effects. Conclusions: This systematic review of animal studies suggests a possible mechanistic association between the consumption of certain artificial sweeteners and systemic inflammation. However, this relationship remains to be clarified and warrants exploration through well-designed, large-scale randomized controlled trials.

Background/Objectives: The execution of clinical trials is increasingly constrained by operational complexity, regulatory requirements, and variability in site performance. These challenges have direct implications for the reliability of trial outcomes. However, standardized methods to evaluate site-level performance remain underdeveloped. This study introduces the Clinical Trial Site Performance Measure (CT-SPM), a novel framework designed to systematically capture site-level operational quality and to provide a scalable short form for routine monitoring. Methods: We conducted a multicenter study across six Italian academic hospitals (January–June 2025). Candidate performance indicators were identified through a systematic review and expert consultation, followed by validation and reduction using advanced statistical approaches, including factor modeling, ROC curve analysis, and nonparametric scaling methods. The CT-SPM was assessed for structural validity, discriminative capacity, and feasibility for use in real-world settings. Results: From 126 potential indicators, 18 were retained and organized into four domains: Participant Retention and Consent, Data Completeness and Timeliness, Adverse Event Reporting, and Protocol Compliance. A bifactor model revealed two higher-order dimensions (participant-facing and data-facing performance), highlighting the multidimensional nature of site operations. A short form comprising four items demonstrated good scalability and sufficient accuracy to identify underperforming sites. Conclusions: The CT-SPM represents an innovative, evidence-based instrument for monitoring trial execution at the site level. By linking methodological rigor with real-world applicability, it offers a practical solution for benchmarking, resource allocation, and regulatory compliance. This approach contributes to advancing clinical research by providing a standardized, data-driven method to evaluate and improve performance across networks.