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New treatment option for Bile Acid Diarrhea
Official title Treatment of Bile Acid Diarrhoea With Atorvastatin
ClinicalTrials.gov ID: NCT07042165
What this study is testing
What is Atorvastatin?
Atorvastatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bile acid diarrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join if
- Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or...
- Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective...
- 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
See the full eligibility criteria
- 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
- 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
- Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator
- Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator
- Alcohol consumption exceeding 12 units/week for women or 18 units/week for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver
- Drug abuse, at the discretion of the investigator
- Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen...
- Pregnant or nursing women
- Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet
- Receipt of any investigational drug within 30 days prior to visit 0
- Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir...
- Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements
- Active participation in any other clinical intervention trial (observational studies not included)
- Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation
The study team makes the final eligibility decision.
Where it's taking place
- Hellerup, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hellerup, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.