The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000102279
Ethics application status
Approved
Date submitted
8/12/2017
Date registered
23/01/2018
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotic Treatment for Huntington's Disease?
Scientific title
Does probiotic treatment of the gut affect the brain of people with Huntington's Disease?
Secondary ID [1] 292300 0
None
Universal Trial Number (UTN)
Trial acronym
GBA-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 303829 0
Condition category
Condition code
Neurological 303203 303203 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention group will receive a probiotic capsule (oral administration) to be taken twice daily for six weeks.

Each capsule contains 22.5 billion live probiotic organisms (Lactobacillus rhamnosus - 10 billion CFU organisms, Saccharomyces cerevisiae - 7.5 billion CFU organisms and Bifidobacterium animalis ssp lactis - 5 billion CFU organisms).

Adherence to the intervention will be monitored via the following methods: Electronic reminders sent to each participant (daily), weekly phone calls to monitor adherence, updates about the study to increase engagement and capsule return.
Intervention code [1] 298474 0
Treatment: Other
Comparator / control treatment
Participants assigned to the placebo group will receive a placebo capsule (oral administration) to be taken twice daily for six weeks.

Both groups will be randomised to either probiotic intervention or placebo.

The placebo is Microcrystalline Cellulose.

The control group consists of healthy controls (not diagnosed with any other neurological condition or illness). These participants will be matched to the HD group based on education, gender and age.

Adherence to the intervention will be monitored via the following methods: Electronic reminders sent to each participant (daily), weekly phone calls to monitor adherence, updates about the study to increase engagement and capsule return.
Control group
Placebo

Outcomes
Primary outcome [1] 303148 0
The primary outcome will be HD-CAB Composite Scores (i.e., composite scores of the Symbol Digits Modalities Task; Paced Tapping; One Touch Stockings; Emotion Recognition; Trail Making Test B; Hopkins Verbal Learning Test).

These scores will be calculated for the HD and control groups.
Timepoint [1] 303148 0
Participants will be assessed twice (once at baseline and again 6-weeks later).
Secondary outcome [1] 338034 0
Quality of life, as measured by HDQLIFE score.
Timepoint [1] 338034 0
Participants will be assessed twice (once at baseline and again 6-weeks later).
Secondary outcome [2] 342287 0
Gut Microbiome Analysis - as measured by levels of bacteria in the gut.
Timepoint [2] 342287 0
Participants will be assessed twice (once at baseline and again 6-weeks later).

Eligibility
Key inclusion criteria
Healthy control and Huntington's disease participants aged 18-70 will be eligible barring they do not violate any of the exclusion criteria.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for all participants includes; diagnosis of any other major neurological disorder, traumatic brain injury, drug or alcohol dependency (in the last 3 months), recent diagnosis of major depression or psychosis, consumption of oral antibiotics (in the past 6 months), high daily consumption of probiotic or fermented foods (foods preserved in high amounts of bacteria) within six weeks prior to the study. Further exclusion includes hospitalised patients with a central venous catheter, people with allergies to yeast, people with a diagnosis of Irritable Bowel Syndrome, Celiac's disease or Crohn's disease and people who are severely ill and/or immunocompromised.

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)
We will be using numbered containers as well as a randomization matrix to ensure double blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be utilised.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Whilst it is difficult to conduct sufficient power analysis, considering the novelty of this research trial, analyses based on previous research with effect sizes of f(V) =0.2 indicates that a total sample size of at least 62 would be required for sufficient power.

We will conduct a 2 (HD & Controls) x 2 (Probiotic & Placebo) x (2) (Time -Baseline & 6 weeks post baseline) factorial anova to measure whether the HD-CAB composite score significantly improves following probiotic intervention between groups.

Although a minimum sample size of 62 is needed, our desired sample size is 80, given the novelty of the research, and our ability to recruit this many participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18013 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 296843 0
University
Name [1] 296843 0
Monash University
Address [1] 296843 0
Monash Institute of Cognitive and Clinical Neurosciences
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Australia
Country [1] 296843 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Institute of Cognitive and Clinical Neurosciences
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 297458 0
Individual
Name [1] 297458 0
Professor Julie Stout
Address [1] 297458 0
Monash Institute of Cognitive and Clinical Neurosciences
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Australia
Country [1] 297458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298074 0
Monash University Human Research Ethics
Ethics committee address [1] 298074 0
Monash University
Clayton Campus, Clayton VIC 3800
Australia
Ethics committee country [1] 298074 0
Australia
Date submitted for ethics approval [1] 298074 0
06/06/2017
Approval date [1] 298074 0
27/06/2017
Ethics approval number [1] 298074 0
2017-8031

Summary
Brief summary
Our study will be the first to characterize the gut microbiome in Huntington's disease (HD). Despite strong evidence in animal model studies, highlighting the interplay between the gut microbiome and cognition, there is lack of translation between these studies and evidence in humans. We intend to address this gap, by assessing cognition, mood and quality of life in the context of a randomized controlled trial using probiotics. Additionally, we will examine the gut microbiome in different stages of HD, which may provide valuable understanding about disease progression.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1892 1892 0 0
Attachments [2] 2165 2165 0 0
Attachments [3] 2166 2166 0 0
Attachments [4] 2167 2167 0 0

Contacts
Principal investigator
Name 75906 0
Prof Julie Stout
Address 75906 0
Monash Institute of Cognitive and Clinical Neurosciences (MICCN)
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Australia
Country 75906 0
Australia
Phone 75906 0
+61 3 9905 3987
Fax 75906 0
Email 75906 0
julie.stout@monash.edu
Contact person for public queries
Name 75907 0
Mr Cory Wasser
Address 75907 0
Monash Institute of Cognitive and Clinical Neurosciences (MICCN)
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Australia
Country 75907 0
Australia
Phone 75907 0
+61 3 9905 4685
Fax 75907 0
Email 75907 0
cory.wasser@monash.edu
Contact person for scientific queries
Name 75908 0
Mr Cory Wasser
Address 75908 0
Monash Institute of Cognitive and Clinical Neurosciences (MICCN)
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Australia
Country 75908 0
Australia
Phone 75908 0
+61 3 9905 4685
Fax 75908 0
Email 75908 0
cory.wasser@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage, we do not plan on sharing IPD. We will review this once we have finished recruiting our participants.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 936 0
Ethical approval
Citation [1] 936 0
Link [1] 936 0
Email [1] 936 0
Other [1] 936 0
Summary results
No Results