Clinical trials

This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy. All consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.

This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS "S. de Bellis". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied

The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome. The main questions it aims to answer are: Does Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life. Participants will: Be randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period

MASLD is currently one of the most common chronic non-communicable diseases and the leading cause of liver-related mortality and morbidity, with a rising prevalence worldwide, especially in the presence of obesity, diabetes, and other cardio-metabolic risk factors. Lifestyle modification, particularly through the Mediterranean Diet, is the first-line intervention, and extra virgin olive oil is a key component thanks to its monounsaturated fatty acids and bioactive compounds with anti-inflammatory and antioxidant effects. Several studies indicate that extra virgin olive oil supplementation, especially within a Mediterranean Diet pattern, reduces hepatic steatosis, improves inflammation, oxidative stress, and glucose and lipid profiles, and may promote weight loss and reduction of fat mass, also through potential effects on the gut microbiota. EFSA recognizes protective effects with a daily intake of at least 20 g of extra virgin olive oil, but it is still unclear whether this amount is optimal for individuals with MASLD, particularly those who are overweight or obese

This study focuses on patients with colorectal cancer undergoing surgery for the primary tumor and/or liver metastases. Tumor samples collected during surgery will be used to generate patient-derived models (primary cultures, spheroids, and organoids) to study colorectal cancer stem cells. The main objective is to investigate the role of the lysine methyltransferase SMYD3 in metabolic reprogramming and adaptation to oxidative stress that enable colorectal cancer cells to survive and grow in the liver. Previous work has shown that SMYD3 is overexpressed in colorectal cancer, promotes drug resistance, and regulates key oncogenic pathways, including c-MYC and the AMPK/mTOR axis. By identifying SMYD3-dependent pathways and pharmacologic vulnerabilities in cancer stem cells within liver metastases, this study aims to support the development of new therapeutic strategies that combine SMYD3 inhibitors with approved or experimental agents targeting tumor metabolism and oxidative stress responses

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.

The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).

The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults. The main questions it aims to answer are: How does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions? Researchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes. Participants will: Provide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms

The study in question is an observational study that aims to identify new non-invasive biomarkers present in the serum of patients with CRC and, subsequently, to create a score capable of predicting the development of CRC. It is an observational study with 3 enrollment arms: Arm 1: Patients undergoing surgery at the U.O.C. of Surgery, with a CRC diagnosis; Arm 2: Subjects with a negative result from the endoscopic examination; Arm 3: Subjects in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.

Liver diseases represent a significant public health problem, with a high prevalence and a growing incidence worldwide, and a significant impact on global morbidity and mortality, causing approximately 2 million deaths annually. Deaths are largely attributable to complications of cirrhosis and hepatocellular carcinoma. The most common causes of cirrhosis worldwide are related to viral hepatitis, alcohol, and non-alcoholic fatty liver disease caused by poor dietary habits. Regarding the hepatitis B virus (HBV), the vaccination program, together with the improvement of socioeconomic conditions and greater public awareness, have progressively reduced the incidence and prevalence of this viral disease. Chronic hepatitis related to the hepatitis C virus (HCV), after an increase in the 1980s and 1990s, is showing a decreasing trend, particularly among younger age groups. While other studies have focused on liver diseases of metabolic origin, the most recent epidemiological data concerning the Italian population were collected in the late 1990s. Since a decade has now passed, it was thought that it might be interesting to collect new data on the prevalence pattern of liver diseases, especially in southern Italy, particularly in a municipality equally geographically distant from both the coast and the inland. Therefore, this observational study aims to analyze the evolution of liver diseases through the recall of a cohort of patients already identified in the Mediterranean area. The cohort is composed of individuals residing in the municipality of Putignano (BA) who have already undergone evaluation of liver function, comorbidities and dietary habits, in addition to adding genetic information through genome-wide association (GWAS) analyses, useful for identifying associations between genetic variants and specific phenotypic characteristics

Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis. The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery. Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it. Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy. The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected.

The aim of the study therefore is to permanently resolve the existence of the bleeding sites caused by Gave and reduce both bleeding episodes and the need for transfusion in such patients applying "Barrx" (trademark) radiofrequency endoscopic ablation technology in selected cohort of patients that will be defined the patient inclusion section.

This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.

This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis. The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis. Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body. The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis

The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota