{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T06:12:45Z","timestamp":1793167965987,"version":"4.5.0"},"reference-count":33,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"unspecified","delay-in-days":27,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007403","name":"Dagmar Marshalls Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007403","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The Foundation for the Advancement of Medical Science under The A.P. M\u00f8ller and Chastine Mc-Kinney M\u00f8ller Foundation","award":["2024-00869"],"award-info":[{"award-number":["2024-00869"]}]},{"name":"Prosector Axel S\u00f8eborg Ohlsen\u2019s Memorial Grant","award":["32804"],"award-info":[{"award-number":["32804"]}]},{"name":"Aase and Ejnar Danielsen\u2019s Foundation","award":["25-10-0342"],"award-info":[{"award-number":["25-10-0342"]}]},{"name":"Doctor Sofus Carl Emil Friis and wife Olga Doris Friis\u2019 Grant","award":["1175555"],"award-info":[{"award-number":["1175555"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,14]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Bile acid diarrhoea (BAD) is a chronic disease with typical symptoms of daily watery stools with increased frequency and urgency. BAD arises due to pathologically high levels of bile acids in the colon, which may be due to impaired reabsorption or increased synthesis. Evidence indicates that atorvastatin administration suppresses bile acid synthesis in healthy individuals, likely due to reduced substrate availability. The Bile Acid diarrhoea STAtin Trial aims to investigate whether atorvastatin treatment reduces bile acid synthesis in patients with BAD and consequently alleviates BAD symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      20 adults with moderate-to-severe BAD, assessed by the gold standard diagnostic test\n                      <jats:sup>75<\/jats:sup>\n                      selenium homotaurocholic acid test, will be randomised to begin with either placebo or atorvastatin 40\u2009mg once daily for 2\u2009weeks, followed by 80\u2009mg once daily for another 2\u2009weeks. After a 4-week washout period, participants will cross over to the alternate treatment. The primary endpoint is the relative difference between atorvastatin and placebo treatment in bile acid synthesis rate, measured by the validated biomarker 7alpha-hydroxy-4-cholesten-3-one (C4) and key secondary endpoints include mean differences in daily stool frequency.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study is approved by the Danish Medicines Agency and the Regional Scientific Ethics Committee of the Capital Region of Denmark (2025-521\u2009856-47-00) and registered with the Danish Data Protection Agency (p-2024-17870). The study is monitored by the Capital Region of Denmark\u2019s Good Clinical Practice unit. All results will be disseminated at national and\/or international scientific meetings and in peer-reviewed scientific journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT07042165\">NCT07042165<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-119827","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T12:20:32Z","timestamp":1785241232000},"page":"e119827","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["BASTA trial: protocol for a randomised, double-blind, placebo-controlled, crossover trial investigating the effects of atorvastatin on bile acid diarrhoea"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct07042165","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5663-0234","authenticated-orcid":false,"given":"Mads Bank","family":"Lynggaard","sequence":"first","affiliation":[{"name":"Center for Clinical Metabolic Research, Copenhagen University Hospital \u2013 Herlev and Gentofte, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00f3lv\u00e1 Str\u00f8m","family":"Olsen","sequence":"additional","affiliation":[{"name":"Center for Clinical Metabolic Research, Copenhagen University Hospital \u2013 Herlev and Gentofte, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie Lyng","family":"Forman","sequence":"additional","affiliation":[{"name":"Section of Biostatistics, Department of Public Health, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin Lund","family":"K\u00e5rhus","sequence":"additional","affiliation":[{"name":"Center for Clinical Metabolic Research, Copenhagen University Hospital \u2013 Herlev and Gentofte, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9462-4468","authenticated-orcid":false,"given":"Lise Lotte","family":"Gluud","sequence":"additional","affiliation":[{"name":"Gastro Unit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asger Bach","family":"Lund","sequence":"additional","affiliation":[{"name":"Center for Clinical Metabolic Research, Copenhagen University Hospital \u2013 Herlev and Gentofte, Hellerup, Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Steno Diabetes Center Copenhagen, Herlev, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4389-3908","authenticated-orcid":false,"given":"Anne-Marie","family":"Ellegaard","sequence":"additional","affiliation":[{"name":"Center for Clinical Metabolic Research, Copenhagen University Hospital \u2013 Herlev and Gentofte, Hellerup, Denmark"},{"name":"Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,7,28]]},"reference":[{"key":"2026072805202100000_16.7.e119827.1","unstructured":"Camilleri M , BouSaba J . 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