None listed
Conditions
Brief summary
The aim of this study is to determine the efficacy of Livaux, a prebiotic supplement made from gold kiwifruit, in improving the gut microbiome and symptoms of constipation in patients with diagnosed Parkinson's disease. Approximately 50 patients will be randomised to receive either 2400mg of Livaux or placebo daily for six weeks in a double-blind cross-over study. The study will last for approximately 20 weeks with a 4-week screening period, two 6-week treatment periods with a washout period of 4 weeks in between. Patients will be required to maintain a bowel diary for the duration of the study, provide food and fluid diaries during the screening and treatment periods, and provide faecal and other specimens on four occasions to enable quantification of the microbiome and its metabolites. Colonic transit time will be measured at the end of each treatment period to determine the effect of transit time on constipation. The final study endpoints will be to determine whether Livaux has any impact on transit time and the quality of the microbiome.
Interventions
Participants will be randomised to receive 1200 mg of Livaux™, a prebiotic supplement made from gold kiwifruit, or identical placebo capsules twice daily for 6 weeks with a washout period of 4 weeks during treatment periods. Treatment will be monitored by a study doctor and adherence will be monitored through regular phone and email contact with the participant and a returned pill count at the end of each treatment period.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Parkinson’s disease according to UK Parkinson’s Disease Society Brain Bank Diagnostic Criteria 2. Currently meet ROME IV criteria for functional constipation 3. Experience 3 or fewer bowel motion days per week 4. 18 years or older 5. BMI range 19-35 6. Prepared to maintain current dietary habits for the duration of the study
Exclusion criteria
1. Allergy to Kiwifruit 2. Allergy to latex 3. Clinically significant (as defined by local PI) gastrointestinal disorders not limited to: • Inflammatory Bowel Disease • History of major GI surgery • Structural or metabolic diseases affecting GI system 4. Other identifiable cause of constipation such as other neurological diseases, peripheral neuropathy, iatragenic constipation 5. Clinically significant or respiratory, cardiac failure or other concurrent medical conditions as defined by local PI 6. Current or recent use (within 2 weeks of baseline) of probiotics including • Probiotic yoghurt or probiotic yoghurt drinks, • fermented foods such as sauerkraut, tempeh, kimchi, miso, pickles • fermented drinks such as kombucha 7. Current or recent use (within 2 weeks of baseline) of the following medications: • Opiate analgesics • Artane • Cogentin • Drugs with a low therapeutic index (warfarin, digoxin) • Antacids containing magnesium or aluminium salts • Anticholinergics • Antibiotics (within 6 weeks of baseline) • SSRIs, SNRIs, or Tricyclic antidepressants (unless on a stable dosing regime) 8. History of laxative abuse 9. A high-fibre diet defined by >50g fibre per day 10. High fibre supplements 11. Females of child-bearing potential
Outcome results
None listed