None listed
Conditions
Brief summary
This study aims to test the efficacy of prucalopride for the management of gastrointestinal symptoms of systemic sclerosis (scleroderma), We hypothesise that prucalopride will reduce the burden of gastrointestinal symptoms in patients with systemic sclerosis (scleroderma) compared to placebo. The primary outcome of interest in this study is patient symptoms and the effects of treatment on people's perceived burden of gastrointestinal symptoms. In addition, we will undertake testing of the changes in whole gut transit time, measured by serial x-rays, and gut microbiome (assessed by faecal specimen) in response to treatment.
Interventions
Intervention;
Prucalopride
2mg, administered orally, once daily for 6 weeks
Participants will cycle through four treatment cycles, alternating between prucalopride and placebo. Participants and study investigators will be blinded to treatment assignment in each treatment cycle. Treatment cycles will be 6 weeks in length. There will be a one week washout period between treatment cycles, during which participants will take no medication or placebo tablets.
All participants will receive 2mg of p
Intervention; Prucalopride 2mg, administered orally, once daily for 6 weeks Participants will cycle through four treatment cycles, alternating between prucalopride and placebo. Participants and study investigators will be blinded to treatment assignment in each treatment cycle. Treatment cycles will be 6 weeks in length. There will be a one week washout period between treatment cycles, during which participants will take no medication or placebo tablets. All participants will receive 2mg of prucalopride / 2mg placebo in each treatment cycle, with burden of gastrointestinal symptoms assessed at the end of each treatment cycle. Treatment adherence will be assessed at the end of every 2nd treatment cycle, by study investigators, by counting number of tablets remaining at the end of the treatment cycles. The study will take place at an urban tertiary hospital.
Sponsors
St Vincent's Hospital Melbourne
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 80 Years
Healthy volunteers
No
Inclusion criteria
Confirmed diagnosis of systemic sclerosis as per 2013 ACR/EULAR classification criteria Age between 18 and 80 years At least one regular symptom of gastrointestinal dysmotility, e.g. difficulty swallowing, nausea, early satiety, vomiting, abdominal bloating or discomfort, diarrhoea, constipation Confirmed gastrointestinal dysmotility by whole gut transit study
Exclusion criteria
• Current use of prokinetic medication (e.g. metoclopramide, domperidone, erythromycin, prucalopride, octreotide, anticholinesterase inhibitor) • Current antibiotic treatment for small intestinal bacterial overgrowth (Patients are ineligible for this study if they have used any antibiotics in the 4 weeks prior to baseline study visit. Meaning patients who are on long term or cyclical antibiotics for management of SIBO will be ineligible for inclusion in this study.) • Current use of GLP-1 receptor agonist • Current use of opiate analgesia • Requirement for enteral or parenteral feeding • Pregnant and or breast-feeding • Individuals not fluent in English or unable to read English.
Outcome results
None listed