[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-acid-malabsorption\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-acid-malabsorption":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994",false,"NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[25,26,27,28,29,30,31,32,33],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[35,36,37],"gut microbiota","Bile Acids","dysbiosis","RECRUITING","2026-02-17",{"date":41,"type":42},"2026-02-24","ACTUAL",{"date":44,"type":42},"2025-09-24",{"date":46,"type":21},"2027-10",{"name":48,"class":49},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100618972","magnesium-in-gastrointestinal-disease-100618972","NCT07338565","Magnesium in Gastrointestinal Disease","Magnesium Status in Patients With Gastrointestinal Disease","MAGIC","Inclusion Criteria:\n\n\\- Age 18 or older, mentally competent, and able to understand Danish.\n\nGroup 1:\n\n\\- Diagnosed with IBD (DK50X, Crohn's disease, or DK51X, ulcerative colitis), ileostomy (DZ932) or bile acid diarrhoea (DSK908B) (Se-HCAT scintigraphy showing residual activity \\\u003C10%).\n\nGroup 2:\n\n\\- Healthy individuals.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Use of oral magnesium supplements for more than 2 weeks before inclusion.",true,{"count":61,"type":21},120,"Individuals with gastrointestinal diseases - such as Crohn's disease, ulcerative colitis, ileostomy, or bile acid diarrhoea - are at increased risk of magnesium deficiency. Magnesium is a vital mineral that supports many essential functions in the body, including muscle contraction, nerve signalling, heart rhythm, and bone health. Deficiency may contribute to fatigue, muscle cramps, abnormal heart rhythms, and reduce the quality of life.\n\nThe purpose of this study is to investigate the prevalence of magnesium deficiency in individuals with these conditions and to identify the most accurate and practical methods for assessing magnesium status in clinical care.\n\nAlthough plasma magnesium is commonly used in routine blood tests, it represents only about 1% of the body's total magnesium and may not reflect true magnesium levels within cells or tissues. Hence, this study compares several different ways of measuring magnesium, including:\n\n* Plasma magnesium\n* Magnesium levels in red and white blood cells (PBMC, RBC, and buffy coat)\n* Magnesium levels in muscle tissue (via biopsy)\n* A magnesium retention test, based on how much magnesium is excreted after an infusion\n\nThe study includes four groups:\n\n1. Patients with inflammatory bowel disease.\n2. Patients with an ileostomy.\n3. Patients with bile acid diarrhoea.\n4. Healthy individuals (control group).\n\nAll participants will provide blood and urine samples, and some may undergo optional biopsies of muscle or intestinal tissue. Participants will also complete questionnaires and undergo tests of muscle strength and body composition.\n\nThe findings are expected to enhance the understanding and detection of magnesium deficiency in patients with gastrointestinal diseases and to aid in the development of more effective tools for identifying and treating this common yet often overlooked condition.",[64,65,66,67,68,69,70,71,32,72,73,74],"Colitis Ulcerosa","Colitis Ulcerative","Crohns Disease","Morbus Crohn","Ileostomy - Stoma","Ileostoma","Ileostomies","Bile Acid Diarrhea","Magnesium Deficiency","Magnesium Level","Magnesium","2026-01-05",{"date":77,"type":42},"2026-01-14",{"date":79,"type":42},"2025-11-03",{"date":81,"type":21},"2027-12-01",{"name":83,"class":49},"University of Aarhus",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":50},"100554716","bile-acids-and-microbiome-in-early-colorectal-carcinogenesis-100554716","NCT06502704","Bile Acids and Microbiome in Early Colorectal Carcinogenesis","Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis","Inclusion Criteria:\n\n\\- Patients that have clinical indications for colonoscopy\n\nExclusion Criteria:\n\n* Pregnancy\n* Immunocompromised\n* Previously diagnosed colorectal diseases\n* Radiotherapy to the pelvis\n* Long term antibiotic use within 6 months\n* Continuous use of proton pump inhibitors",{"count":92,"type":21},60,"Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma.\n\nAdult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (\\\u003C1cm) adenomas, large (\\>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling.\n\nThe investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.",[95,96,97,98,32],"Colorectal Neoplasms","Colorectal Cancer","Colorectal Polyp","Microbiome",[95,96,97,98,100],"Bile Acid","2024-07-08",{"date":103,"type":42},"2024-07-16",{"date":105,"type":21},"2024-07-05",{"date":107,"type":21},"2025-01-01",{"name":109,"class":49},"Vilnius University"]