Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• age 18 years or above
• Self-identification as White
• Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
• Reported number of average daily stools ≥ 3 stools per day
• Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)
• Informed and written consent
Locations
Other Locations
Denmark
Center for Clinical Metabolic Research, Gentofte Hospital
RECRUITING
Hellerup
Contact Information
Primary
Asger B Lund, MD, PhD
asger.lund.01@regionh.dk
+4538672461
Time Frame
Start Date:2025-10
Estimated Completion Date:2026-12
Participants
Target number of participants:20
Treatments
Placebo_comparator: Placebo
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).
Experimental: Atorvastatin
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).
Collaborators: Fonden til Lægevidenskabens Fremme, Prosektor Axel Søeborg Ohlsens Mindelegat, Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat