None listed
Conditions
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.
Interventions
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 (
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed