DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations.

Introduction: The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.

Autobrewery Syndrome and Endogenous Ethanol Production in Patients with MASLD: A Perspective from Chronic Liver Disease.

Autobrewery syndrome is a rare condition characterized by the endogenous fermentation of carbohydrates by gut microbiota, which exceeds the liver's detoxification capacity and leads to signs and symptoms of acute alcohol intoxication. This condition has significant clinical, social, and legal implications. Beyond the acute effects, the role of excessive endogenous ethanol production in the progression of chronic diseases-particularly liver disease-is still under investigation.

Intestinal inflammation and microbiota modulation impact cochlear function: emerging insights in gut-ear axis.

Background: Although several evidence demonstrates a "gut-microbiota-brain axis", suggesting a bidirectional communication between gut microbiota and the central nervous system, less is known about a possible link between the gut and the peripheral nervous system, including the inner ear.

Methods: Here, we investigated the impact of intestinal inflammation and the modulation of gut microbiota through fecal microbiota transplantation on hearing sensitivity. Female C57BL/6 mice were assigned to four groups: control (Ctrl), DSS-induced colitis (DSS), FMT from patients with active ulcerative colitis (FMT aUC), and FMT from patients with ulcerative colitis in remission (FMT rUC).

Gut microbiota and atherosclerosis.

Atherosclerosis reflects a chronic inflammatory process of arteries. The origin of chronic vascular inflammation has been associated over a long time primarily with lipid disorders, but evidence from the past years has suggested that lipid-independent pathways are also involved. Recent research has demonstrated that the gastrointestinal microbiota has an impact on the development of atherosclerosis.

The Lancet Child & Adolescent Health Commission on the future of neonatology.

Neonatal mortality remains unacceptably high throughout the world. Survival of sick infants in their first month of life has improved over the past six decades. However, many comorbidities persist, with lifelong implications for health.

Fecal Microbiome Transplantation for Recurrent CDI: Treatment Efficacy and Safety with Oral Capsules.

Background And Aims: Fecal microbiota transplantation is an effective treatment method for recurrent Clostridioides difficile infection. Widely used enteric tube and colonoscopy methods demonstrate excellent efficacy and safety results. Recent data suggest that new fecal microbiota transplantation methods using oral capsules may provide a less invasive approach.

Cancer Vaccines: A Promising Therapeutic Strategy in Advanced Solid Tumors.

Recent advancements in understanding how cancer cells evade immune recognition have led to significant progress in cancer immunotherapy. Therapeutic cancer vaccines hold great promise due to their safety, specificity, and ability to establish lasting immune memory, serving as an effective immunotherapy either alone or in combination with other treatments in clinical research. Cancer vaccines aim to restore the host's innate and adaptive anti-cancer immune responses by stimulating antigen-presenting processes and reversing the immunosuppressive environment that facilitates tumor immune evasion and metastasis.

The Multi-Faceted Role of Gut Microbiota in Alopecia Areata.

Alopecia areata (AA) is a complex autoimmune disorder with multifactorial pathogenesis. Recent research highlights the gut microbiota as a possible key player in AA pathogenesis through the gut-skin axis: gut dysbiosis may disrupt intestinal barrier integrity and immune tolerance by affecting T regulatory cells, potentially contributing to disease onset and progression. The purpose of this review is to analyze the current evidence on the correlation between gut microbiota and AA, dissecting both the pathogenetic role of its alterations in the onset and progression of disease and its potential role as a therapeutic target.

The microbiome for clinicians.

Despite promising evidence in diagnostics and therapeutics, microbiome research is not yet implemented into clinical medicine. Several initiatives, including the standardization of microbiome research, the refinement of microbiome clinical trial design, and the development of communication between microbiome researchers and clinicians, are crucial to move microbiome science toward clinical practice.

Multistrain Probiotics Plus Vitamin D Improve Gut Barrier Function and Gut Microbiota Composition in Irritable Bowel Syndrome Without Constipation: Results from a Double-Blind, Randomized, Placebo-Controlled Trial.

Background: The disruption of the intestinal barrier and the imbalance of the gut microbiota (GM) seem to play a major role in the complex pathogenesis of irritable bowel syndrome (IBS). Specific microbial strains could improve the gut microenvironment, promoting anti-inflammatory pathways; similarly, vitamin D supplementation could play a role in enhancing the barrier integrity and modulating the immune response in the gut. This study aims to evaluate the efficacy of a new multistrain probiotic, combined with vitamin D, in improving gut barrier function in IBS without constipation.

Preferred Reporting Items for Microbiotherapy (PRIM) Guidelines Across Medical Disciplines: An International Delphi Consensus.

Microbiotherapy has opened new avenues for managing dysbiosis-related diseases. However, many studies did not cover all the necessary reporting items for microbiotherapy making the interpretation of results, safety assessment, technology extension, and even the transparency of legitimacy difficult. This project consisted of 2 phases.

Machine Learning and Artificial Intelligence in the Multi-Omics Approach to Gut Microbiota.

The gut microbiome is involved in human health and disease, and its comprehensive understanding is necessary to exploit it as a diagnostic or therapeutic tool. Multi-omics approaches, including metagenomics, metatranscriptomics, metabolomics, and metaproteomics, enable depiction of the gut microbial ecosystem's complexity. However, these tools generate a large data stream in which integration is needed to produce clinically useful readouts, but, in turn, might be difficult to carry out with conventional statistical methods.

The Detrimental Impact of Ultra-Processed Foods on the Human Gut Microbiome and Gut Barrier.

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.

From big data and experimental models to clinical trials: Iterative strategies in microbiome research.

Microbiome research has expanded significantly in the last two decades, yet translating findings into clinical applications remains challenging. This perspective discusses the persistent issue of correlational studies in microbiome research and proposes an iterative method leveraging in silico, in vitro, ex vivo, and in vivo studies toward successful preclinical and clinical trials. The evolution of research methodologies, including the shift from small cohort studies to large-scale, multi-cohort, and even "meta-cohort" analyses, has been facilitated by advancements in sequencing technologies, providing researchers with tools to examine multiple health phenotypes within a single study.

Meta-Analysis: Inverse Association Between Helicobacter pylori Infection and Eosinophilic Oesophagitis.

Background: Exposure to Helicobacter pylori (H. pylori) has been associated with a decreased risk of eosinophilic oesophagitis (EoE).

Aim: The aim of this study is to determine the association between H.

Guidance for Fecal Microbiota Transplantation Trials in Ulcerative Colitis: The Second ROME Consensus Conference.

Background: Fecal microbiota transplantation (FMT) is emerging as a potential treatment modality for individuals living with inflammatory bowel disease (IBD). Despite its promise, the effectiveness of FMT for treating IBD, particularly for ulcerative colitis (UC), still requires thorough clinical investigation. Notwithstanding differences in methodologies, current studies demonstrate its potential for inducing remission in UC patients.

Comparative efficacy of different techniques for colonic endoscopic submucosal dissection: A network meta-analysis of randomized controlled trials.

Background: Endoscopic submucosal dissection (ESD) is an advanced technique that can provide successful 'en-bloc' and R0 resection rate for large gastrointestinal lesions. To date, several ESD techniques have been proposed, but their comparative efficacy is still unclear.

Methods: Major databases were systematically searched for RCTs comparing the efficacy and safety of different ESD techniques for the resection of colonic lesions.