Gut Microbiome Study
This clinical trial is looking at constipation and gut dysfunction and is being conducted at the University of Queensland under the guidance of A/professor John O’Sullivan. The purpose of this study is to determine the effectiveness of a prebiotic medication for the treatment of constipation in people with Parkinson’s Disease.
This trial will evaluate the efficacy of prioritised repurposed drugs as promising disease-modifying treatments for Parkinson’s disease. These drugs have been shortlisted by the Cure Parkinson’s Trust Linked Clinical Trials (LCT) program and have been rigorously evaluated for their potential to slow or halt the progression of the disease.
Phase II clinical trials will be conducted at major South East Queensland hospitals and clinical research centres. We will be recruiting at:
• Royal Brisbane Hospital and UQ Centre for Clinical Research (UQCCR)
• Wesley Medical Research
• Gold Coast University Hospital
QDRI-001 – A Double blind, placebo-controlled, crossover trial of Livaux TM for the treatment of functional constipation in patients with Parkinson’s Disease
The purpose of this study is to determine the effectiveness of a prebiotic medication for the treatment of constipation in people with Parkinson’s Disease.
There will be a total of 50 participants enrolled over approximately three sites. Participant involvement in the trial will last 20 weeks, which will include five visits to the study clinic.
Eligibility
Participants must be:
- Diagnosed with idiopathic Parkinson’s Disease
- Have a history of constipation and difficulty having a bowel movement.
- Drink at least 1.5 litres of fluid daily.
What to expect
This is a cross over study which means you will receive both the active drug and placebo throughout the study. You will receive either study medication or a placebo (a placebo is a medication with no active ingredients).
Study activities will include:
• A physical examination – measurement of vital signs (heart rate, and blood pressure), a collection of blood, saliva, urine, and stool samples.
• Undergoing two abdominal X-rays
• Maintain a regular stool diary.
• Completing a number of Parkinson’s disease assessments at each of the five visits.
The study has been ethically approved by the Royal Brisbane and Women’s Hospital,
RBWH-Ethics@health.qld.gov.au.
If you are interested please contact the clinical trials team below
Centre for Clinical Research – University of Queensland (uq.edu.au)
Clinical Trials Coordinator
Helen Woodhouse
Email: qdri.research@uq.edu.au
Tel: 07 3346 5043 or 0456 104 909
