Treatment of Bile Acid Diarrhoea With Atorvastatin
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsger Lund, MD
About this 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.
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 criteria
Qualifiers
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
Disqualifiers
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)
Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit
If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial
Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above
Trial design
Treatments tested in this trial
- Atorvastatin
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Asger Lund, MD
Lead sponsor
University Hospital, Gentofte, Copenhagen
Sponsor institution
Fonden til Lægevidenskabens Fremme
Collaborator
Prosektor Axel Søeborg Ohlsens Mindelegat
Collaborator
Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat
Collaborator
Aase and Ejnar Danielsens Foundation
Collaborator
Source ClinicalTrials.gov