Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001186640
Ethics application status
Approved
Date submitted
25/10/2023
Date registered
16/11/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial of a prebiotic powder for symptoms of Parkinson’s disease
Scientific title
The effect of OM002 on symptom alleviation in Parkinson’s Disease
Secondary ID [1] 310841 0
None
Universal Trial Number (UTN)
Trial acronym
CC in PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease (constipation and cognitive decline) 331854 0
Condition category
Condition code
Neurological 328597 328597 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will receive 10 grams of OM002 once daily (soluble powder dissolved in any liquid) for 13 weeks in addition to the standard of care. Following this period both groups will receive an open-label 10 grams of OM002 for an additional 13 weeks.

Adherence will be monitoring via daily notifications and medication diary using MyCap (an application associated with the REDCap data management system) as well as study product return (at 6-weekly clinic visits)
Intervention code [1] 327253 0
Treatment: Drugs
Comparator / control treatment
Control group will receive 5 grams of placebo (maltodextrin) for 13 weeks in addition to the standard of care. Following this period, control participants will receive an open-label 10 grams of OM002 for an additional 13 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 336400 0
Constipation will be assessed as a composite outcome that includes complete spontaneous bowel motions and change in stool consistency.
Timepoint [1] 336400 0
Baseline, mid-treatment (6 weeks post-baseline), completion of first arm (13 weeks post-baseline), mid-open-label treatment (19 weeks post-baseline), and at the end of the open-label treatment period (26 weeks post-baseline)
Secondary outcome [1] 428171 0
Cognitive decline
Timepoint [1] 428171 0
Baseline, mid-treatment (6 weeks post-baseline), completion of first arm (13 weeks post-baseline), mid-open-label treatment (19 weeks post-baseline), and at the end of the open-label treatment period (26 weeks post-baseline)
Secondary outcome [2] 428172 0
Motor function disease progression
Timepoint [2] 428172 0
Baseline, mid-treatment (6 weeks post-baseline), completion of first arm (13 weeks post-baseline), mid-open-label treatment (19 weeks post-baseline), and at the end of the open-label treatment period (26 weeks post-baseline)

Eligibility
Key inclusion criteria
1. Males and females
2. Adults aged greater than or equal to 18 years of age
3. A clinical diagnosis of idiopathic PD according to the UK Parkinson's disease Society Brain Bank Diagnostic Criteria
4. Being managed by a neurologist
5. Willing to maintain current diet (and any pre- or pro-biotic regime)

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Secondary Parkinsonism
2. Tube feeding
3. Medical or surgical disorders preventing completion of questionnaires and significant cognitive impairment demonstrated by an incapacity to provide consent (including diagnosis of advanced cognitive impairment)
4. Pregnancy
5. Smokers
6. Oral antibiotics in the last 3 months

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)
Central randomisation in REDCap database (computer program)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks of 20
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary efficacy endpoint is the Overall Responder rate for constipation at Week 13. This is a composite endpoint which considers improvement from Baseline in the frequency and consistency of bowel movements.

Secondary efficacy endpoints (all Baseline to Week 13) include change in MOCA score, change in stool frequency (mean CSBMs per week), mean change in BSFS, percentage of participants with a =1-point improvement in BSFS score.
Linear mixed models estimated via maximum likelihood will include treatment group, time (stage of trial) and the interaction between these. The treatment effect will be evaluated through the interaction term. For quantitative outcomes formal statistical inference will employ the nonparametric bootstrap using 2000 bootstrap samples. For binary outcomes mixed effects logistic regression will be used. Missing data will not be imputed for continuous endpoints unless otherwise specified in the statistical analysis plan. All p values will be based on 2-sided tests. A multiple testing procedure for the control of type I error may be employed and will be specified in the statistical analysis plan prior to breaking the treatment blind.

All tests will be repeated for the 13-to-26-week period when all participants will have consumed OM002 for 13 weeks (control group) or 26 weeks (intervention group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
9/05/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25773 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment hospital [2] 25774 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 41598 0
2031 - Randwick
Recruitment postcode(s) [2] 41599 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 315088 0
Commercial sector/Industry
Name [1] 315088 0
Intrinsic Medicine AU PTY LTD
Country [1] 315088 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 317111 0
None
Name [1] 317111 0
Address [1] 317111 0
Country [1] 317111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314034 0
Hunter New England Human Research Ethics Commmittee
Ethics committee address [1] 314034 0
Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 314034 0
Australia
Date submitted for ethics approval [1] 314034 0
29/09/2023
Approval date [1] 314034 0
20/10/2023
Ethics approval number [1] 314034 0
HNEHREC/ETH01902

Summary
Brief summary
OM002 is a synthetic oligosaccharide that is identical to the human milk oligosaccharide (HMO) 2’ fucosyllactose (2'FL) and has the potential to address the underlying pathophysiology of Parkinson’s Disease (PD) constipation and address unmet clinical needs in these patients. This study is being conducted to assess the safety and efficacy of OM002 relating to reduced severity of constipation and disease progression in patients with PD. This double-blind, randomized, placebo-controlled study trial will consist of two groups (n=80/each) who will receive either OM002 or placebo for 13 weeks in addition to the standard of care. Following this period both groups will receive an open-label for an additional 13 weeks. Biological samples and surveys will be sampled at 5 time points (baseline, mid-treatment, completion of first arm (13 weeks), mid-open-label treatment, and at the end of the open-label treatment period (13 weeks)). Trial data will be used in combination with available open-label data to guide the late-stage development of OM002 in participants with PD. We hypothesise that ingestion of 10 grams of OM002 daily will improve cognitive function and reduce GI symptom severity in patients diagnosed with PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130190 0
Prof Nicholas Talley
Address 130190 0
Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW 2305
Country 130190 0
Australia
Phone 130190 0
+61 2 4042 0000
Fax 130190 0
Email 130190 0
nicholas.talley@newcastle.edu.au
Contact person for public queries
Name 130191 0
Dr Kerith Duncanson
Address 130191 0
Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW 2305
Country 130191 0
Australia
Phone 130191 0
+61 428 848 264
Fax 130191 0
Email 130191 0
kerith.duncanson@newcastle.edu.au
Contact person for scientific queries
Name 130192 0
Dr Kerith Duncanson
Address 130192 0
Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW 2305
Country 130192 0
Australia
Phone 130192 0
+61 428 848 264
Fax 130192 0
Email 130192 0
kerith.duncanson@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Group level participant data as requested by funding partner and ethics approval.


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.