None listed
Conditions
Brief summary
Fatigue is a common and debilitating symptom of primary biliary cholangitis (PBC), yet no approved treatments currently exist. Creatine, through its beneficial effects on mitochondrial function, muscular metabolism, and neuroprotection, represents a biologically plausible therapeutic option to treat symptoms associated with PBC. This is the first study of its kind with aims to assess whether creatine supplementation improves fatigue, quality of life, liver biochemistry, and muscle function in patients with PBC. If effective, creatine could offer a safe, accessible, and cost-effective strategy for managing fatigue in this population.
Interventions
The study is a dual-centre, 18-week, randomised, double-blinded, placebo-controlled crossover trial at Sunshine Coast University Hospital and Gold Coast University Hospital, designed to evaluate the effects of creatine on clinical outcomes in PBC patients. It features two 6-week experimental periods separated by a 6-week washout, with measures taken before and after each period. Participants are randomly assigned to sequence groups.
The primary aim is to assess if creatine improves fatigue (PROM
The study is a dual-centre, 18-week, randomised, double-blinded, placebo-controlled crossover trial at Sunshine Coast University Hospital and Gold Coast University Hospital, designed to evaluate the effects of creatine on clinical outcomes in PBC patients. It features two 6-week experimental periods separated by a 6-week washout, with measures taken before and after each period. Participants are randomly assigned to sequence groups. The primary aim is to assess if creatine improves fatigue (PROMIS Fatigue Short Form 7a). Secondary outcomes include quality of life (PBC-40, Pittsburgh Sleep Quality Index), liver biochemistry (alkaline phosphatase), and muscular function (hand-grip strength, maximal voluntary contraction, motor unit activity via first dorsal interosseous electromyography). Participants will take 5 grams of creatine (in tablet form) daily for the duration of the treatment period. In the control arm, a placebo will be used (in tablet form of equivalent doses). As this is a crossover trial, there is a 6-week washout period between treatments to prevent carry-over effects. The duration of each treatment period is 6 weeks, with the total study lasting 18 weeks. Participants will be asked to keep dosing diaries, recording daily intake and timing. Participants are asked to maintain habitual physical activity during testing days, ensuring standardisation.
Sponsors
IPSEN
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or over with confirmed diagnosis of PBC and a baseline PROMIS Fatigue Short Form 7a of greater than or equal to a score of 14.
Exclusion criteria
Under 18 years of age, pregnant, breastfeeding, end stage chronic kidney disease, known allergy to creatine supplementation Any PBC-related medication changes within the last 3 months prior to commencement of the study. Use of creatine in the last 14 days.
Outcome results
None listed