[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596185":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":58,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Gentofte, Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Placebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be administering one tablet for two weeks followed by two tablets for two weeks. Then four weeks of washout before entering the atorvastatin arm (crossover).",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Atorvastatin","EXPERIMENTAL","40 mg Atorvastatin tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the placebo tablets except containing the active ingredient (atorvastatin). Participants will be administering one tablet for two weeks followed by two tablets for two weeks (80 mg atorvastatin). Then four weeks of washout before entering the placebo arm (crossover).",[19],"Drug: Atorvastatin",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will be orally administering one tablet daily of 40 mg Atorvastatin for two weeks followed by two tablets daily for two weeks (totalling 80 mg daily).",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be orally administering one tablet daily for two weeks followed by two tablets daily for two weeks.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Asger B Lund, MD, PhD","CONTACT","+4538672461","asger.lund.01@regionh.dk",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Center for Clinical Metabolic Research, Gentofte Hospital","RECRUITING","Hellerup","2900","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],12.57093,55.73204,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":25,"email":53},"Mads B Lynggaard, MD","+4521689048","mads.bank.lynggaard@regionh.dk",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Asger Lund, MD","MD, PhD",[59,61,63,65],{"name":60,"class":6},"Fonden til Lægevidenskabens Fremme",{"name":62,"class":6},"Prosektor Axel Søeborg Ohlsens Mindelegat",{"name":64,"class":6},"Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat",{"name":66,"class":6},"Aase and Ejnar Danielsens Foundation","100596185","phase-4-treatment-of-bile-acid-diarrhoea-with-atorvastatin-100596185",false,"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","ALL","18 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85,86],"Bile Acid Diarrhea","Bile Acid Malabsorption",[85,86,15,88,9,89,90,91,92,93],"Randomised","7-alpha-C4","Crossover","Double-blind","Investigator-initiated","Proof of concept","2025-11-24",{"date":96,"type":97},"2025-12-02","ACTUAL",{"date":99,"type":97},"2025-10-15",{"date":101,"type":79},"2026-12",{"name":56,"class":6},1]