Treatment of Bile Acid Diarrhoea with Atorvastatin (BASTA)

Not yet recruiting

Conditions: Bile acid diarrhoea

Registration Number: 2025-521856-47-00

Lead Sponsor: Gentofte Hospital

Brief Summary: 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 moderate-severe bile acid diarrhoea.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %

Exclusion Criteria

History of/present hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and/or alanine aminotransferase and/or serum aspartate aminotransferase ≥ 3 times upper limit of normal

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Secondary Outcome Measures

Name	Time	Method
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.		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.
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.		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.
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		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

Trial Locations

Locations (1): Gentofte Hospital
🇩🇰
Hellerup, Denmark
Gentofte Hospital
🇩🇰Hellerup, Denmark
Asger Bach Lund
Site contact
21689048
asger.lund.01@regionh.dk