[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":396},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,71,107,134,160,188,210,240,262,285,306,328,351,374],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100644359","fib-4-cut-offs-for-liver-fibrosis-in-obese-endocrinology-patients-100644359",false,"NCT07663188","FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients","Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy","OBEMASLD","Inclusion Criteria:\n\n* Obesity class I or II (body mass index, BMI ≥ 30 kg\u002Fm² and ≤ 40 kg\u002Fm²)\n* Age \\> 18 years and \\\u003C 65 years.\n* Ability to provide written informed consent after adequate information on the study objectives.\n* Arm 1: patients with FIB-4 ≥ 1.3.\n* Arm 2: patients with FIB-4 \\\u003C 1.3.\n\nExclusion Criteria:\n\n* Lack of signed informed consent.\n* Pregnancy or breastfeeding.\n* Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).\n* Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).","ALL","18 Years","65 Years",{"count":21,"type":22},400,"ESTIMATED","OBSERVATIONAL","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.\n\nAll 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.",[26],"MASLD",[26,28],"FIB-4","NOT_YET_RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":22},"2026-09-01",{"date":37,"type":22},"2028-09-01",{"name":39,"class":40},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100642297","molecular-characterization-of-autoimmune-hepatitis-a-lipidomic-approach-100642297","NCT07644936","Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach","Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study","AIH-LIPID","Inclusion Criteria:\n\nARM A:\n\n* Confirmed diagnosis of autoimmune hepatitis (AIH);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nARM B:\n\nExclusion Criteria:\n\n* Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nEsclusion Criteria:\n\n* Liver cirrhosis;\n* Active oncological diseases;\n* Viral hepatitis (HBV, HCV, HIV infection);\n* Severe medical conditions that may compromise study participation",{"count":50,"type":22},24,"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",[53,54],"Autoimmune Hepatitis","Non-Alcoholic Fatty Liver Disease",[56,57,58,59,60,61],"autoimmune hepatitis","lipidomic analysis","extracellular vesicles","fatty acids","biomarkers","NAFLD","2026-06-15",{"date":64,"type":33},"2026-06-16",{"date":66,"type":22},"2026-07-01",{"date":68,"type":22},"2028-07-01",{"name":39,"class":40},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497","NCT07577089","Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)","Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome","FD-CBT","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Functional Dyspepsia according to Rome IV criteria\n* Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)\n* Active symptoms within the last month\n* Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)\n* History of major abdominal surgery affecting the stomach or small intestine\n* Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation\n* Current participation in other interventional clinical trials\n* Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)\n* Pregnancy or breastfeeding",{"count":80,"type":22},90,"INTERVENTIONAL",[83],"NA","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.\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\nBe 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",[86,87,88],"Functional Dyspepsia","Epigastric Pain Syndrome","Postprandial Distress Syndrome",[86,90,87,88,91,92,93,94,95,96,97,98],"Cognitive Behavioral Therapy","Gut-Brain Axis","Microbiota","Randomized Controlled Trial","Disorders of Gut-Brain Interaction","Gastrointestinal Symptoms","Inflammation","Biomarkers","Precision Medicine","2026-05-05",{"date":101,"type":33},"2026-05-11",{"date":103,"type":22},"2026-04",{"date":105,"type":22},"2028-12",{"name":39,"class":40},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":116,"targetDuration":4,"studyType":81,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":70},"100624654","evoo-and-metabolic-liver-health-in-masld-100624654","NCT07412444","EVOO and Metabolic Liver Health in MASLD","Evaluation of the Effects of Extra Virgin Olive Oil Consumption on Hepatic Steatosis Parameters and on Glucose and Lipid Metabolism in Subjects With MASLD.","EvoLiveR","Inclusion Criteria:\n\n* Subjects with 20 ≤ BMI \\\u003C 30;\n* Age range between 18 and 65 years, both sexes;\n* Diagnosis of hepatic steatosis, made on the basis of recognized criteria (FibroScan \\[CAP (controlled attenuation parameter) \\> 288 dB\u002Fm\\], FLI).\n\nExclusion Criteria:\n\n* Subjects with BMI \\\u003C 20 and BMI \\> 30.\n* Presence of any condition that may influence the occurrence of steatosis other than the conditions representing inclusion criteria.\n* Pregnancy or breastfeeding.\n* Severe medical conditions that may compromise participation in the trial.\n* Individuals following a special diet.",true,{"count":117,"type":22},60,[83],"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.\n\nSeveral 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",[121,122],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Overweight",[26,122,124,125,126],"EVOO","Glucose Metabolism","Lipid Metabolism","RECRUITING",{"date":129,"type":33},"2026-05-06",{"date":129,"type":33},{"date":132,"type":22},"2028-05-06",{"name":39,"class":40},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100631216","smyd3-driven-metabolic-rewiring-in-colorectal-liver-metastases-100631216","NCT07497789","SMYD3-Driven Metabolic Rewiring in Colorectal Liver Metastases","Targeting SMYD3-Driven Metabolic Rewiring and Oxidative Stress Adaptation in Colorectal Liver Metastases","AIRC_ IG 34634","Inclusion Criteria:\n\nCommon criteria\n\n* Age ≥ 18 years.\n* Availability of residual tumor tissue from the surgical procedure that is not required for diagnostic purposes.\n* Signed written informed consent for the use of biological samples for research purposes.\n\nCohort\u002FArm 1 (Colon-rectal tumor resection)\n\n\\- Patients undergoing surgical resection of colorectal cancer.\n\nCohort\u002FArm 2 (Primary tumor and liver metastases resection) - Patients undergoing surgical resection of the primary colorectal tumor and liver metastases from colorectal carcinoma.\n\nCohort\u002FArm 3 (Liver metastases resection only)\n\n\\- Patients undergoing surgical resection of liver metastases from colorectal carcinoma previously resected at the primary site.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Undergoing surgical intervention for a malignancy other than those specified in the inclusion criteria.\n* Lack of signed informed consent",{"count":143,"type":22},156,"This study focuses on patients with colorectal cancer undergoing surgery for the primary tumor and\u002For 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\u002FmTOR 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",[146,147],"CRC (Colorectal Cancer)","Liver Metastases From Colorectal Primary Cancer",[149,150,151],"Colorectal cancer","liver metastases","liver metastases from colorectal cancer","2026-03-31",{"date":154,"type":33},"2026-04-06",{"date":156,"type":22},"2026-05-10",{"date":158,"type":22},"2028-05-10",{"name":39,"class":40},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":19,"enrollmentInfo":169,"targetDuration":4,"studyType":81,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":187,"locationsCount":70},"100587085","exercise-interventions-and-dietary-advice-in-fibromyalgia-and-ibs-100587085","NCT06923800","Exercise Interventions and Dietary Advice in Fibromyalgia and IBS","Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study","FM-IBS","Inclusion Criteria:\n\n* Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III\u002FIV diagnostic criteria for IBS.\n* Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) ≥ 125 (indicating moderate to severe IBS symptoms).\n* Men and women aged between 30 and 65 years.\n* Body Mass Index (BMI) between 18.5 and 29.9.\n\nExclusion Criteria:\n\n* Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.\n* Individuals unable to discontinue symptom management therapies and medications for FM\u002FIBS.","30 Years",{"count":170,"type":22},30,[83],"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.\n\nThe 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.\n\nGastrointestinal 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.\n\nFM 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.\n\nExercise, 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.",[174,175],"Fibromyalgia","Irritable Bowel Syndrome",[177,178,179,180],"exercise","aerobic exercise","fibromyalgia","irritable bowel syndrome","2026-03-24",{"date":183,"type":33},"2026-03-27",{"date":185,"type":33},"2025-04-14",{"date":105,"type":22},{"name":39,"class":40},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":196,"targetDuration":4,"studyType":81,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":70},"100530445","effects-of-two-different-exercise-programs-and-diet-in-obese-subjects-with-nafld-100530445","NCT06186869","Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD","Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD","Obesity_AF","Inclusion Criteria:\n\n* BMI ≥ 30 kg\u002Fm2 or an abdominal circumference (waist) \\> 94 cm in men and \\> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterise metabolic syndrome\n* Age range 18-65 years, both sexes\n* Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \\> 238 dB\u002Fm)).\n\nExclusion Criteria:\n\n* Normal and underweight subjects\n* Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases\n* Pregnancy or breastfeeding\n* Subjects with osteoarticular pathologies that may prevent regular exercise\n* Inability to quantify the degree of NAFLD by Fibroscan\n* Person not in possession of a medical certificate of fitness for non-competitive physical activity.",{"count":80,"type":22},[83],"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\u002Fm).",[200,61],"Obesity",[200,202,203,61],"Physical Exercise","systemic inflammation",{"date":183,"type":33},{"date":206,"type":33},"2023-10-02",{"date":208,"type":22},"2026-12-23",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":220,"conditions":221,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":70},"100622247","bariatric-surgery-and-gut-microbiota-changes-over-time-100622247","NCT07381140","Bariatric Surgery and Gut Microbiota Changes Over Time","Longitudinal Evaluation of Gut Microbiota and Fecal Metabolome Following Roux-en-Y Gastric Bypass: Clinical Implications and Identification of Predictive Biomarkers","RYGB-MICROGUT","Inclusion Criteria (RYGB Group):\n\n* Age between 18 and 65 years.\n* Adults with a body mass index (BMI) ≥ 35 kg\u002Fm² with related comorbidities, or BMI ≥ 40 kg\u002Fm², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only.\n\nExclusion Criteria (RYGB Group):\n\n* Treatment with antibiotics within the last 3 weeks, or probiotics\u002Fprebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0).\n* Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment.\n* Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms.\n* Previous organ transplant or ongoing systemic immunosuppressive therapy.\n* Pregnancy or breastfeeding.\n* Previous major gastrointestinal surgery.\n* Chronic alcohol consumption above moderate levels or substance use disorder.\n\nInclusion Criteria (Obese Control Group):\n\n* Age between 18 and 65 years.\n* Adults with BMI ≥ 30 kg\u002Fm² who are candidates for structured dietary treatment.\n\nInclusion Criteria (Healthy Control Group):\n\n* Age between 18 and 65 years.\n* Normal weight (BMI between 18.5 and 24.9 kg\u002Fm²).\n* Normal metabolic function: fasting glucose below threshold, normal ALT\u002FAST, no diagnosis of diabetes or metabolic syndrome.\n* No chronic gastrointestinal diseases or conditions that could alter the gut microbiota.\n\nExclusion Criteria (Obese Control and Healthy Control Group):\n\n* Use of antibiotics within the last 3 weeks or probiotics\u002Fprebiotics within the last 4-6 weeks.\n* Recent gastrointestinal surgery.\n* Pregnancy or breastfeeding.\n* Extreme diets or recent dietary changes.\n* Recent international travel that could have affected the gut microbiota.\n* Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids).\n* Active smoking or excessive alcohol consumption.\n* Significant gastrointestinal symptoms (chronic diarrhea or constipation).",{"count":219,"type":22},100,"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.\n\nThe main questions it aims to answer are:\n\nHow 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?\n\nResearchers 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.\n\nParticipants will:\n\nProvide 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",[222,223,224,225],"Obese Patients","Obese Patients With Bariatric Surgery","Gut Microbiota","Healthy Participants",[227,228,229,230,231,232],"gut microbiota","stool metabolome","obesity","bariatric surgery","Roux-en-Y gastric bypass","Long-read sequencing","2026-02-03",{"date":235,"type":33},"2026-02-05",{"date":103,"type":22},{"date":238,"type":22},"2028-04",{"name":39,"class":40},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":70},"100604741","identification-of-new-non-invasive-predictive-and-diagnostic-biomarkers-for-colorectal-cancer-100604741","NCT07153458","Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer","Inclusion Criteria:\n\n* AIM 1: Patients undergoing surgery at the U.O.C. of Surgery, with a diagnosis of CRC.\n* AIM 2: Subjects without colon disease.\n* AIM 3: Subjects with adenoma and high-grade dysplasia.\n\nExclusion Criteria:\n\n* Subject with any other pathology not included in the inclusion criteria.",{"count":117,"type":22},"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.\n\nIt is an observational study with 3 enrollment arms:\n\nArm 1: Patients undergoing surgery at the U.O.C. of Surgery, with a CRC diagnosis;\n\nArm 2: Subjects with a negative result from the endoscopic examination;\n\nArm 3: Subjects in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.",[146,249],"Adenoma Colon",[251,252,97,253],"crc (colorectal cancer)","Adenoma colon","neoplasm","2025-12-12",{"date":256,"type":33},"2025-12-19",{"date":258,"type":33},"2025-12-01",{"date":260,"type":22},"2027-12-01",{"name":39,"class":40},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":4},"100587710","recall-of-a-cohort-of-subjects-in-the-mediterranean-area-monitoring-of-liver-diseases-nutrihep-3-100587710","NCT06931925","Recall of a Cohort of Subjects in the Mediterranean Area. Monitoring of Liver Diseases (NUTRIHEP 3).","Nutrihep3","Inclusion Criteria:\n\n* \\>18 Years\n* Resident of Putignano (BA -Italy)\n\nExclusion Criteria:\n\n* \\\u003C 18 years",{"count":270,"type":22},2300,"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.\n\nDeaths are largely attributable to complications of cirrhosis and hepatocellular carcinoma.\n\nThe most common causes of cirrhosis worldwide are related to viral hepatitis, alcohol, and non-alcoholic fatty liver disease caused by poor dietary habits.\n\nRegarding 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",[273],"Cohort Study",[273,275,26,276],"GWAS","Liver Diseases","2025-04-17",{"date":279,"type":33},"2025-04-22",{"date":281,"type":22},"2025-09-01",{"date":283,"type":22},"2027-09-01",{"name":39,"class":40},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":70},"100544678","changes-in-the-lipidomic-immunological-and-mirna-profile-in-patients-undergoing-a-dietary-program-or-bariatric-surgery-100544678","NCT06372015","Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery","Changes in the Lipidomic, Immunological and Circulating microRNA Profile in Patients With Hepatobiliary Pathology, Suffering From Morbid Obesity Undergoing a Dietary Program or Bariatric Surgery","Inclusion Criteria:\n\n* Obese patients (BMI \\>30kg\u002Fm2) suffering from hepato-biliary pathology diagnosed by Fibroscan\n* Adult patients (\\>18 years).\n\nExclusion Criteria:\n\n* Patients who are not obese or not affected by hepato-biliary pathology",{"count":117,"type":22},"Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\\>30 kg\u002Fm2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.\n\nThe 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.\n\nBariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.\n\nAmong the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.\n\nThe 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.",[200,295],"Liver Disease Parenchymal",[200,276,297],"Bariatric Surgery","2025-04-02",{"date":300,"type":33},"2025-04-04",{"date":302,"type":33},"2024-06-01",{"date":304,"type":22},"2026-06-01",{"name":39,"class":40},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100579901","study-on-the-efficacy-of-endoscopic-radiofrequency-treatment-in-reducing-the-need-for-blood-transfusions-in-gave-100579901","NCT06830317","Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE","A Multicenter, Observational, Prospective Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions Compared with Conventional Therapies in Patients with Gastric Antral Vascular Ectasia (GAVE)","GAVE","Inclusion Criteria:\n\n* At least 18 years of age\n* Existing diagnosis of GAVE (validated by an external expert)\n* Melena and\u002For hematemesis secondary to GAVE and\u002For iron deficiency anemia persisting despite systemic iron therapy or oral supplementation and\u002For (concentrated red globules) GRC transfusions for at least 6 months\n* Negative colonoscopy (performed within 12 months prior to enrollment, exclusion of any site of bleeding)\n* Able to comply with study requirements and understand and sign the informed consent form\n\nExclusion Criteria:\n\n* Alternative causes for iron deficiency anemia (gastro-duodenal erosions and\u002For ulcerations, celiac disease, Inflammatory Bowel Disease (IBD), etc)\n* Pregnancy\n* Active malignancy (malignancy diagnosed in past five years or ongoing treatment)\n* Anatomical malformations precluding treatment with RFA\n* Blood coagulation deficit: International normalized ratio (INR)\\>2, Platelets (PLT) \\\u003C50,000",{"count":315,"type":22},80,"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.",[318],"GAVE - Gastric Antral Vascular Ectasia",[320],"GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION","2025-02-11",{"date":323,"type":33},"2025-02-17",{"date":298,"type":22},{"date":326,"type":22},"2027-09-02",{"name":39,"class":40},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":115,"sex":17,"minAge":168,"maxAge":19,"enrollmentInfo":336,"targetDuration":4,"studyType":81,"phases":337,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100563411","intermittent-fasting-mediterranean-diet-and-nafld-100563411","NCT06615817","Intermittent Fasting, Mediterranean Diet and NAFLD","Comparison Between 14\u002F10 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score, Inflammatory Indices and Intestinal Microbiota","RC2024-21","Inclusion Criteria:\n\n* Medium\u002Fsevere NAFLD (CAP\\>268)\n* BMI between 25 and 35\n\nExclusion Criteria:\n\n* diabetes treated with insulin,\n* fatty liver disease linked to alcohol consumption,\n* chronic inflammatory intestinal and oncological diseases,\n* visceral obesity which does not allow good resolution of Fibroscan images,\n* subjects in serious medical conditions that may compromise participation in the trial,\n* people following a special diet or unable to follow a diet for religious or other reasons.\n* Pregnancy and breastfeeding",{"count":117,"type":22},[83],"This study aims to evaluate the effects of Intermittent Fasting (IF) 14\u002F10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.",[61,200,340,341],"Intermittent Fasting","Mediterranean Diet",[200,276],"2024-10-22",{"date":345,"type":33},"2024-10-26",{"date":347,"type":22},"2025-01-01",{"date":349,"type":22},"2027-01-01",{"name":39,"class":40},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":358,"targetDuration":4,"studyType":81,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":70},"100475921","evaluation-of-gut-permeability-in-patients-affected-by-obesity-and-nafld-influence-of-ketogenic-diet-100475921","NCT05477212","Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.","Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet on Diagnostic and Prognostic Markers in Liver Disease","Inclusion Criteria:\n\n1. BMI ≥ 30 Kg\u002Fm2 or abdominal circumference (waist) \\>94 cm in men and \\>80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome\n2. Age range between 18 and 70 years, both sexes\n3. Diagnosis of hepatic steatosis, formulated on the basis of fibroscan \\[CAP (controlled attenuation parameter) \\> 238 dB\u002Fm(decibel\u002Fmeter)\\], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).\n\nExclusion Criteria:\n\n1. Normal and underweight subjects\n2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria\n3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis\n4. Pregnancy or lactation",{"count":170,"type":22},[83],"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.\n\nThe first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis.\n\nIntestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body.\n\nThe second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis",[362,61,200],"Permeability; Increased",[229,364,61,365],"Gut permeability","Ketogenic diet","2024-10-01",{"date":368,"type":33},"2024-10-02",{"date":370,"type":33},"2022-04-28",{"date":372,"type":22},"2025-05-28",{"name":39,"class":40},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":395,"locationsCount":4},"100553415","evaluation-of-the-variation-of-the-intestinal-microbiota-and-the-integrity-of-the-intestinal-barrier-in-patients-with-mdr-germ-induced-pneumonia-undergoing-enteral-nutrition-100553415","NCT06485791","Evaluation of the Variation of the Intestinal Microbiota and the Integrity of the Intestinal Barrier in Patients With M.D.R. Germ-induced Pneumonia Undergoing Enteral Nutrition","Inclusion Criteria:\n\n* Patients admitted to the Intensive Care Unit suffering from lung infections caused by M.D.R. germs.\n\nExclusion Criteria:\n\n* Patients hospitalized with other pathologies",{"count":381,"type":22},50,"The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota",[384,385],"Multi Drug Resistant","Dysphagia",[387,388],"Antibiotic resistance","Enteral nutrition","2024-06-26",{"date":391,"type":33},"2024-07-03",{"date":393,"type":22},"2024-07-01",{"date":66,"type":22},{"name":39,"class":40},""]