[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-acid-diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-acid-diarrhea":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,74,106],{"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":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"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":51,"type":20},120,"OBSERVATIONAL","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.",[55,56,57,58,59,60,61,27,26,62,63,64],"Colitis Ulcerosa","Colitis Ulcerative","Crohns Disease","Morbus Crohn","Ileostomy - Stoma","Ileostoma","Ileostomies","Magnesium Deficiency","Magnesium Level","Magnesium","2026-01-05",{"date":67,"type":32},"2026-01-14",{"date":69,"type":32},"2025-11-03",{"date":71,"type":20},"2027-12-01",{"name":73,"class":39},"University of Aarhus",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"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":83,"type":20},20,[85],"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],[27,26,89,90,91,92,93,94,95,96],"Atorvastatin","Randomised","Placebo","7-alpha-C4","Crossover","Double-blind","Investigator-initiated","Proof of concept","2025-11-24",{"date":99,"type":32},"2025-12-02",{"date":101,"type":32},"2025-10-15",{"date":103,"type":20},"2026-12",{"name":105,"class":39},"Asger Lund, MD",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":40},"100536020","the-8x5-diet-for-bile-acid-diarrhoea-a-feasibility-randomised-controlled-trial-100536020","NCT06259396","The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years, of any ethnic group, living in the United Kingdom and not planning to move home for the next three months\n* Self-reported diagnosis of bile acid diarrhoea that was confirmed by 7-day SeHCAT testing\n* Self-reported ongoing chronic diarrhoea despite use of appropriate medication\n* Able to participate in either diet group with the intention to remain in the group to which they were assigned for the 8 week study period\n* Body mass index ≥20 kg m-2\n* Able to converse in English (or via their carer, without assistance from an interpreter) using a computer\u002Flaptop, smart phone, or tablet\n* Able to provide informed written consent\n* Able to provide the address of their general practioner so that the research team can inform them of their participation.\n\nExclusion Criteria:\n\n* Unable to provide self-reported written confirmation that their diagnosis of bile acid diarrhoea was by SeHCAT testing\n* Pregnant\u002Fbreastfeeding\u002Fplanning a pregnancy in the next six months\n* Inflammatory bowel disease, previous or current microscopic colitis, or other serious morbidities such as liver disease, pancreatic disease, AIDS\u002FHIV, radiotherapy for cancer, assessed at screening via patient self-report\n* Diarrhoea that is inadequately active: \\<3 stools per day or \\<1 watery stool (Bristol Stool Form types 6-7) per day as the mean of one week\n* Currently participating in another research study or has taken part in the previous 3 months\n* If taking insulin, metformin (other than slow-release), anti-obesity medication, or using commercially available formulated supplements to replace meals in previous three months\n* Use of antibiotics in the previous four weeks\n\nMedically necessary dietary exclusions or issues deemed incompatible with the trial:\n\n* Food allergies, other than oral allergy syndrome\u002Fpollen-food syndrome\n* Exclusion of gluten (i.e. coeliac disease), lactose, biogenic amines, or any other dietary exclusion assessed as unsuitable as screening by the trial team. This includes if the participant knows they would refuse to eat: starchy foods, fruit and vegetables, protein-rich foods, or dairy and alternatives (e.g. following a ketogenic diet)\n* An eating disorder or disordered eating which is active or in the last 12 months\n* Alcohol or drug abuse, or self-harm, or depression, or suicide ideation in the last 12 months\n* Shift worker\n* If unwilling to keep a weighed 7-day food diary",{"count":113,"type":20},76,[23],"Bile acid diarrhoea is a common cause of chronic watery diarrhoea. Treatment is life-long medication. However, about 50% of people have ongoing, bothersome diarrhoea. Findings from recent research on diet therapies and food intolerances have been used to develop a healthy dietary pattern called The 8x5 Diet. We will test the practicalities of conducting a randomised controlled trial of this dietary intervention.",[27],[118,119,120,121,122],"diet intervention","nutrition","feasibility","diarrhoea","adults","2024-12-10",{"date":125,"type":32},"2024-12-16",{"date":127,"type":32},"2024-04-02",{"date":129,"type":20},"2025-03-31",{"name":131,"class":39},"University of Manchester"]