Treatment of Bile Acid Diarrhoea With Atorvastatin

NCT07042165 | Recruiting Phase 4

• 1 other identifier: EU trial no. 2025-521856-47-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bile Acid Diarrhea; Bile Acid Malabsorption

Keywords

Bile Acid Diarrhea; Bile Acid Malabsorption; Atorvastatin; Randomised; Placebo; 7-alpha-C4; Crossover; Double-blind; Investigator-initiated; Proof of concept

Outcome Measures

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.

  The end of week 4 and the end of week 12.

Secondary Outcomes (11)

• Reduction in bile acid synthesis measured via C4

  The end of week 4 and the end of week 12.

• Reduction in BAD symptoms measured via a stool diary.

  Week 4 and week 12.

• A reduction in BAD symptoms measured via a stool diary.

  Week 4 and week 12.

• Symptom severity measured via IBS-SSS

  The end of week 4 and the end of week 12.

• Reduction in bile acid synthesis measured via C4.

  The end of week 4 and the end of week 12.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Atorvastatin

EXPERIMENTAL

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

Interventions

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).

Atorvastatin

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concomitant use of any kind of insulin medication
• Planned major changes in food consumption throughout the trial, including planned weight loss attempts
• Prior use of any statin within the recent 6 months
• Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator
• 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
• Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance
• Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)
• Nephropathy with estimated glomerular filtration rate \< 45 ml/min/1,73 m2
• Plasma level of creatine kinase ≥ 5 times the upper limit of normal
• A recent stroke or transient ischemic attack (within 6 months)
• Any treatment or condition requiring acute or subacute medical or surgical intervention

Sponsors & Collaborators

• Asger Lund, MD: lead
• 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

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Asger B Lund, MD, PhD

CONTACT

+4538672461; asger.lund.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 27, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

DK (1)