A Phase 4 interventional study of Atorvastatin and Placebo in Bile Acid Diarrhea and Bile Acid Malabsorption, sponsored by Asger Lund, MD. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Asger Lund, MD · Phase 4, Interventional, and Treatment
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.
There is an unmet need for more treatment options in patients suffering from BAD.
The 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.
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.
Bile acids are synthesised from cholesterol in hepatocytes through a tightly regulated enzymatic process and then excreted to the gut lumen in response to food ingestion. In a healthy individual 95 % of the bile acids are recycled in the enterohepatic circulation in a tightly regulated process. BAD symptoms arise due to a pathological spill-over of bile acids to the colon.
Currently, individuals with BAD are typically treated with bile acids sequestrants. However, only about 2/3 patients experience an improvement in their symptoms on this treatment. Thus, the possibility of yet another tool in the toolbox is compelling.
Statins are used by millions of patients world-wide to reduce their risk of cardiovascular morbidity and mortality and are considered safe with overall mild and benign adverse effects. Statins lower the intracellular levels of cholesterol in hepatocytes. As such, atorvastatin could potentially reduce the bile acid production in individuals with BAD leading to a reduction or normalisation of the amount of bile acids secreted to the intestinal lumen and entering the colon. Unpublished results from the investigators' group show a 43 % reduction of serum C4, a biomarker of bile acid synthesis which can also be used to diagnose BAD, in healthy, young men, who were treated with atorvastatin for 14 days (7 days of 40 mg atorvastatin once daily followed by 7 days of 80 mg atorvastatin once daily) compared to placebo treatment.
The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea.
The current study aims to investigate whether atorvastatin treatment lowers the synthesis of bile acids, measured via the well-known bile acid synthesis marker C4, in a dose-response manner in patients with severe bile acid diarrhoea. The investigators expect the reduction of bile acid synthesis to lead to a reduction in bile acid diarrhoea symptoms since the pathophysiology of the disease is a spill-over of bile acids to the colon. Specifically, the primary endpoint is the reduction in percentage of C4 at the end of the 80 mg treatment period compared to placebo. Additionally, the investigators will investigate the effect of atorvastatin treatment in patients with severe bile acid diarrhoea on symptoms, hepatobiliary markers, metabolic markers, glycaemic control markers, stool samples and safety.
Asger Lund, MD is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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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).
Drug: Placebo
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).
Drug: Atorvastatin
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).
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.
Reduction in bile acid synthesis measured via 7alpha-Hydroxy-4-cholesten-3-on (C4)
Ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
Time frame: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4
Difference in mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) in μg/L at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
Time frame: The end of week 4 and the end of week 12.
Reduction in BAD symptoms measured via a stool diary.
Difference in mean daily stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by a 7-day stool diary
Time frame: Week 4 and week 12.
A reduction in BAD symptoms measured via a stool diary.
Difference in mean daily watery stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by the total watery (6 or 7 on the Bristol Stool Chart) stools in a 7-day stool diary
Time frame: Week 4 and week 12.
Symptom severity measured via IBS-SSS
Difference in symptom severity measured via a danish translation of the validated questionnaire Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The answers are on a scale of 0-500, where a higher score indicates worse symptoms.
Time frame: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4.
Proportion of patients with a reduction of 7alpha-Hydroxy-4-cholesten-3-on (C4) below 31 μg/L (%)
Time frame: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4
Proportion of patients with a reduction of 7alpha-Hydroxy-4-cholesten-3-on (C4) below 46 μg/L (%)
Time frame: The end of week 4 and the end of week 12.
Bile acid metabolism measured via FGF-19
Fibroblast growth factor 19 (FGF-19) (pg/mL)
Time frame: The end of week 4 and the end of week 12.
Bile acid metabolism measured via blood levels of total bile acids
Blood levels of total bile acids (μmol/L)
Time frame: The end of week 4 and the end of week 12.
Cholesterol metabolism
Total cholesterol (mmol/L)
Time frame: The end of week 4 and the end of week 12.
Cholesterol metabolism
Low-density lipoprotein (LDL) cholesterol (mmol/L)
Time frame: The end of week 4 and the end of week 12.
Bile acid levels measured in stool samples
Stool sample levels of total bile acids (μmol/g)
Time frame: The end of week 4 and the end of week 12.
Plan to share: Yes
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Asger Lund, MD