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Treatment of Bile Acid Diarrhoea With Atorvastatin

ConditionsBile Acid DiarrheaBile Acid Malabsorption
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Atorvastatin

    Drug

    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

    Drug

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: AtorvastatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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