Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000991910
Ethics application status
Approved
Date submitted
19/05/2020
Date registered
1/10/2020
Date last updated
16/12/2022
Date data sharing statement initially provided
1/10/2020
Date results information initially provided
16/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Double-blind, placebo-controlled, cross-over trial of LivauxTM for the treatment of constipation and microbiome restoration in Parkinson’s disease.
Scientific title
Double-blind, placebo-controlled, cross-over trial of LivauxTM for the treatment of constipation and microbiome restoration in Parkinson’s disease.
Secondary ID [1] 301330 0
Nil known
Universal Trial Number (UTN)
U1111-1252-2898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 317532 0
Constipation 317533 0
Condition category
Condition code
Neurological 315623 315623 0 0
Parkinson's disease
Oral and Gastrointestinal 315908 315908 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317627 0
Treatment: Other
Comparator / control treatment
matched placebo comprised of rice starch
Control group
Placebo

Outcomes
Primary outcome [1] 323860 0
Change in the number of complete bowel motions (CBM) per week (CBM defined as a bowel movement after which a feeling of complete evacuation is reported).
Timepoint [1] 323860 0
End of treatment periods at week 6 and 16
Secondary outcome [1] 383076 0
Change in the relative abundance of F.prausnitzii in the gut microbiome as measured through faecal sampling.
Timepoint [1] 383076 0
End of treatment periods at week 6 and 16
Secondary outcome [2] 383820 0
Change in the levels of key microbiome metabolites and disease-relevant immunometabolic markers as measured by blood, urine and faecal sampling
Timepoint [2] 383820 0
End of treatment periods at weeks 6 and 16
Secondary outcome [3] 383821 0
Change in colonic transit time as determined through colonic transit time testing
Timepoint [3] 383821 0
End of treatment periods at weeks 6 and 16
Secondary outcome [4] 416904 0
Total number of bowel movements per week as measured by participant bowel diary.
Timepoint [4] 416904 0
End of treatment periods at weeks 6 and 16
Secondary outcome [5] 416905 0
Spontaneous bowel movements (SBM) / week (SBM defined as bowel movement without manual methods or laxative use in the preceding 24 hours) as measured by participant bowel diary.
Timepoint [5] 416905 0
End of treatment periods at weeks 6 and 16
Secondary outcome [6] 416906 0
Complete spontaneous bowel movements (CSBM) as measured by participant bowel diary
Timepoint [6] 416906 0
End of treatment periods at weeks 6 and 16
Secondary outcome [7] 416907 0
Laxative use /week as measured by participant bowel diary
Timepoint [7] 416907 0
End of treatment periods at weeks 6 and 16
Secondary outcome [8] 416908 0
Colonic transit time (oro-anal transit time = number of retained markers on abdominal x-ray/10)
Timepoint [8] 416908 0
End of treatment periods at weeks 6 and 16
Secondary outcome [9] 416909 0
Patient Assessment of Constipation Symptoms total score
Timepoint [9] 416909 0
End of treatment periods at weeks 6 and 16

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/11/2020
Actual
23/11/2020
Date of last participant enrolment
Anticipated
1/09/2021
Actual
20/04/2022
Date of last data collection
Anticipated
1/02/2022
Actual
13/09/2022
Sample size
Target
20
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16716 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 16718 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30318 0
4029 - Herston
Recruitment postcode(s) [2] 30320 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305764 0
Government body
Name [1] 305764 0
Queensland Government - Advance Queensland Innovation Partnership
Country [1] 305764 0
Australia
Funding source category [2] 305959 0
Charities/Societies/Foundations
Name [2] 305959 0
Wesley Medical Research
Country [2] 305959 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland 4072
Country
Australia
Secondary sponsor category [1] 306203 0
None
Name [1] 306203 0
Address [1] 306203 0
Country [1] 306203 0
Other collaborator category [1] 281324 0
Hospital
Name [1] 281324 0
Royal Brisbane & Women's Hospital
Address [1] 281324 0
Butterfield St
Herston QLD 4029
Country [1] 281324 0
Australia
Other collaborator category [2] 281365 0
Commercial sector/Industry
Name [2] 281365 0
Anagenix
Address [2] 281365 0
Level 1, 272 Parnell Road,
Parnell, Auckland 1052,
New Zealand
Country [2] 281365 0
New Zealand
Other collaborator category [3] 281366 0
Commercial sector/Industry
Name [3] 281366 0
Microba
Address [3] 281366 0
388 Queen St
Brisbane, QLD, Australia 4000
Country [3] 281366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306037 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 306037 0
627 Rode Rd, Chermside QLD 4032
Ethics committee country [1] 306037 0
Australia
Date submitted for ethics approval [1] 306037 0
11/06/2020
Approval date [1] 306037 0
01/10/2020
Ethics approval number [1] 306037 0
HREC/2020/QPCH/61479

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102506 0
Dr John O'Sullivan
Address 102506 0
Centre for Clinical Research
The University of Queensland
Building 71/918, Royal Brisbane & Women’s Hospital
Butterfield St
Herston QLD 4029 Australia
Country 102506 0
Australia
Phone 102506 0
+61 7 3346 5043
Fax 102506 0
Email 102506 0
[email protected]
Contact person for public queries
Name 102507 0
Ms Elizabeth Arnold
Address 102507 0
Centre for Clinical Research
The University of Queensland
Building 71/918, Royal Brisbane & Women’s Hospital
Butterfield St
Herston QLD 4029 Australia
Country 102507 0
Australia
Phone 102507 0
+61 7 3365 5147
Fax 102507 0
Email 102507 0
[email protected]
Contact person for scientific queries
Name 102508 0
Dr John O'Sullivan
Address 102508 0
Centre for Clinical Research
The University of Queensland
Building 71/918, Royal Brisbane & Women’s Hospital
Butterfield St
Herston QLD 4029 Australia
Country 102508 0
Australia
Phone 102508 0
+61 7 3346 5043
Fax 102508 0
Email 102508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.