RecruitingPhase 3ACTRN12621000450819

ULTRA Pain Study - Ursodeoxycholic acid in Low Phospholipid Associated Cholelithiasis (LPAC) Treating Recurrent Abdominal Pain Study

ULTRA Pain Study - Investigating the effectiveness of Ursodeoxycholic acid on Recurrent Abdominal Pain in adults with Low Phospholipid Associated Cholelithiasis (LPAC)


Sponsor

Melbourne Health

Enrollment

24 participants

Start Date

May 10, 2022

Study Type

Interventional

Conditions

Summary

Low Phospholipid Associated Cholelithiasis (LPAC) is a cause of post-operative pain and recurrent gallstones after gallbladder removal (cholecystectomy). This is a randomised control trial of a medication called ursodeoxycholic acid in patients with LPAC to prevent pain post gallbladder surgery, improve quality of life, reduce hospital presentations and patient use of strong narcotic painkillers. This trial is a crossover trial where participants will be randomised to undergo a 1 year experimental (ursodeoxycholic acid) or control arm (placebo). The experimental or control arm will be prescribed a daily dose of 10mg/kg of ursodeoxycholic acid or placebo. Participants will then undergo a 2 week washout period before crossing over to the opposite arm to complete the study. The dose will be prescribed at 10mg/kg daily and can be titrated to a maximum of 20mg/kg daily at the discretion of the treating clinician. The primary study outcome is number of episodes of biliary pain. Secondary outcomes include quality of life, hospitalisations, liver ultrasound findings.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Some people continue to experience severe abdominal pain even after having their gallbladder removed — a condition that can be caused by Low Phospholipid-Associated Cholelithiasis (LPAC), a genetic condition that causes stones to form in the bile ducts inside the liver. This trial tests whether ursodeoxycholic acid, a bile acid medication, can prevent this pain, reduce hospital admissions, and improve quality of life. You may be eligible if you are 18 or older, have had your gallbladder removed, and experience more than two episodes of biliary pain per year, along with at least two other features suggesting LPAC (such as being under 40 at the time of your first biliary symptoms, specific ultrasound findings, or a family history of gallbladder surgery before age 40). People with stones in the common bile duct, inflammatory bowel disease, significant psychiatric disorders, or active pregnancy are not eligible. This is a crossover trial, meaning all participants take the real medication for one year and the placebo for another year (in random order), with a 2-week washout in between. The main outcome is how many pain episodes occur on each treatment. If effective, this medication could offer a much-needed solution for a painful and often misunderstood condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ursodeoxycholic acid capsules orally starting at 10mg/kg daily with the ability to be increased to a maximum of 20mg/kg daily at the treating clinician's discretion if the participant is continuing to

Ursodeoxycholic acid capsules orally starting at 10mg/kg daily with the ability to be increased to a maximum of 20mg/kg daily at the treating clinician's discretion if the participant is continuing to experience biliary pain. In the event of diarrhoea, ursodeoxycholic acid can be down titrated to 5mg/kg and slowly increased as tolerated. Cross-over trial design. Duration is for 1 year (52 weeks) each for ursodeoxycholic acid and placebo. The wash out period is 2 weeks. Adherence is monitored by the Clinical Trials Pharmacy Department who will monitor unused capsules.


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12621000450819