[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,75,107,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100562898","probiotic-in-patients-with-bile-acid-malabsorptiondiarrhea-100562898",false,"NCT06609148","Probiotic in Patients With Bile Acid Malabsorption\u002FDiarrhea","Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption\u002FDiarrhea Unassociated With Ileal Resection","Inclusion criteria:\n\n* Prior diagnosis of bile acid malabsorption documented in the medical history based on\n\n  * either serum C4 \\>52.5ng\u002FmL, or\n  * fecal 48h total BA excretion \\>2337 μmol\u002F48h, or\n  * primary BA \\>5% 48h stool collection or \\>10% in single stool sample.\n* 7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than 5. Note: If Inclusion criteria 3 is not met, participants may choose to have their blood drawn clinically to further determine eligibility.\n* For women of childbearing potential\n\n  * A negative urine pregnancy test prior to dispensing the study product\n  * Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:\n\n    * Surgical sterilization\n    * Hormonal contraception (implantable, patch, oral, intra-muscular)\n    * Intra-uterine device\n    * Double barrier method (diaphragm plus condom)\n    * At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance\n\nExclusion criteria:\n\n* Use of oral antibiotics and probiotics within the last 4 weeks.\n* Pregnancy or lactation.\n* Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study.\n* History of ileal resection.\n* Diabetes mellitus (type 1)\n* BMI ≥ 40 kg\u002Fm\\^2\n* Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 4 weeks\n* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol or could interfere with the study assessments","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.",[26,27],"Bile Acid Malabsorption","Bile Acid Diarrhea","RECRUITING","2026-05-08",{"date":31,"type":32},"2026-05-11","ACTUAL",{"date":34,"type":32},"2025-01-02",{"date":36,"type":20},"2026-06-30",{"name":38,"class":39},"Mayo Clinic","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":62,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":40},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994","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",{"count":50,"type":20},20,"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.",[54,55,56,57,58,59,60,26,61],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Microbial Colonization",[63,64,65],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":68,"type":32},"2026-02-24",{"date":70,"type":32},"2025-09-24",{"date":72,"type":20},"2027-10",{"name":74,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":40},"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":85,"type":20},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.",[88,89,90,91,92,93,94,27,26,95,96,97],"Colitis Ulcerosa","Colitis Ulcerative","Crohns Disease","Morbus Crohn","Ileostomy - Stoma","Ileostoma","Ileostomies","Magnesium Deficiency","Magnesium Level","Magnesium","2026-01-05",{"date":100,"type":32},"2026-01-14",{"date":102,"type":32},"2025-11-03",{"date":104,"type":20},"2027-12-01",{"name":106,"class":39},"University of Aarhus",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":40},"100596185","phase-4-treatment-of-bile-acid-diarrhoea-with-atorvastatin-100596185","NCT07042165","Treatment of Bile Acid Diarrhoea With Atorvastatin","Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial","BASTA","Inclusion Criteria:\n\n* age 18 years or above\n* Self-identification as White\n* Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %\n* Reported number of average daily stools ≥ 3 stools per day\n* Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)\n* Informed and written consent\n\nExclusion Criteria:\n\n* Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)\n* Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit\n* If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial\n* Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above\n* Concomitant use of any kind of insulin medication\n* Planned major changes in food consumption throughout the trial, including planned weight loss attempts\n* Prior use of any statin within the recent 6 months\n* Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator\n* History of\u002Fpresent hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and\u002For alanine aminotransferase and\u002For serum aspartate aminotransferase ≥ 3 times upper limit of normal\n* Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance\n* Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)\n* Nephropathy with estimated glomerular filtration rate \\\u003C 45 ml\u002Fmin\u002F1,73 m2\n* Plasma level of creatine kinase ≥ 5 times the upper limit of normal\n* A recent stroke or transient ischemic attack (within 6 months)\n* Any treatment or condition requiring acute or subacute medical or surgical intervention\n* Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator\n* Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator\n* Alcohol consumption exceeding 12 units\u002Fweek for women or 18 units\u002Fweek for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver\n* Drug abuse, at the discretion of the investigator\n* Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet\u002Fpill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch) associated with inhibition of ovulation, chemical (copper IUD), sterilisation, vasectomised partner with a confirmatory test, or sexual abstinence per the investigator's discretion\n* Pregnant or nursing women\n* Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet\n* Receipt of any investigational drug within 30 days prior to visit 0\n* Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, bocepravir, telaprevir, elbasvir\u002Fgrazoprevir, ledipasvir\u002Fsofosbuvir, erythromycin, niacin, ezetimibe, fusidic acid, gemfibrozil, colchicine, digoxin, warfarin\n* Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements\n* Active participation in any other clinical intervention trial (observational studies not included)\n* Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation",{"count":50,"type":20},[117],"PHASE4","Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.\n\nThere is an unmet need for more treatment options in patients suffering from BAD.\n\nThe investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea. The investigators will investigate this hypothesis in the current study, BASTA, which is a Randomised, Double-Blind, Placebo-Controlled, Crossover, Proof of Concept, Investigator-Initiated, Trial.",[27,26],[27,26,121,122,123,124,125,126,127,128],"Atorvastatin","Randomised","Placebo","7-alpha-C4","Crossover","Double-blind","Investigator-initiated","Proof of concept","2025-11-24",{"date":131,"type":32},"2025-12-02",{"date":133,"type":32},"2025-10-15",{"date":135,"type":20},"2026-12",{"name":137,"class":39},"Asger Lund, MD",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":40},"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":146,"type":20},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.",[149,150,151,152,26],"Colorectal Neoplasms","Colorectal Cancer","Colorectal Polyp","Microbiome",[149,150,151,152,154],"Bile Acid","2024-07-08",{"date":157,"type":32},"2024-07-16",{"date":159,"type":20},"2024-07-05",{"date":161,"type":20},"2025-01-01",{"name":163,"class":39},"Vilnius University"]