None listed
Conditions
Brief summary
This study will be a pilot examination of the effectiveness of a multi-strain probiotic intervention to improve cognitive symptoms (primary outcome variables), and cognition-related fatigue, everyday functioning and health-related quality of life (secondary outcome variables) in people living with Relapsing Remitting MS. The study will also examine the potentially important relationship between gut microbial imbalance, kynurenine pathway biomarkers, and cognitive symptoms in this population. The study will broaden our understanding of the role of the gut-brain connection in MS pathogenesis. It is a requisite step in exploring the innovative application of probiotics to improve cognitive symptomology and associated clinical and psychosocial outcomes in people living with MS.
Interventions
A combination of phase 1 and RCT's have recently demonstrated positive effects of probiotic interventions on brain lesion volume, clinical disability scores, inflammatory cytokine response, mood, and the gut microbiota in MS. This pilot study aims to determine if these effects extend to the kynurenine pathway of tryptophan metabolism and to cognitive symptoms in people living with relapsing remitting MS. The intervention in this study will be an orally administered multi-strain probiotic blend,
A combination of phase 1 and RCT's have recently demonstrated positive effects of probiotic interventions on brain lesion volume, clinical disability scores, inflammatory cytokine response, mood, and the gut microbiota in MS. This pilot study aims to determine if these effects extend to the kynurenine pathway of tryptophan metabolism and to cognitive symptoms in people living with relapsing remitting MS. The intervention in this study will be an orally administered multi-strain probiotic blend, containing live, freeze-dried bacteria, sold under the trade name ‘Vivomixx’ in Australia. It will be given as a 2 x sachet dose (totaling 900 billion CFU) once daily, for a period of 12 weeks. This will be self-administered by participants at home. A fact sheet containing the instructions for preparation and consumption will be provided to participants at the time the intervention is dispensed. This will contain the details from the manufacturers product information card, as well as the study contact, and will be reviewed by both the project team physician (neurologist) and clinical neuropsychologist. All investigators responsible for product dispensing will be appropriately trained in the research protocol including the storage, preparation and consumption instructions of the intervention. Planned assessment of intervention adherence includes a compliance schedule sheet for participants to tick off daily dose (to be returned at their end-of-intervention assessment), brief automated compliance text message at the end of each week asking whether all doses were taken during the week (Y/N) and if no, how many were missed, and return of unused sachets at the end of the 12-week period to be counted and recorded by the study coordinator.
Sponsors
University of Tasmania
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
No
Inclusion criteria
(1) A diagnosis of clinically definite Relapsing Remitting MS, as defined by the McDonald criteria (as diagnosed by their treating neurologist). (2) Aged between 18 and 70 years (3) Able to speak and read English (4) Not currently taking probiotic supplements (5) Have not taken regular probiotic supplements within the previous 3 months or if so, willing to undertake an 8-week washout
Exclusion criteria
(1) A diagnosis of a psychotic, bipolar or related disorder (2) A history of brain injury or other neurological illness (e.g., stroke, epilepsy) (3) A significant history of alcohol or illicit drug abuse (4) MS disease relapse (symptom flare-up) within 2 weeks of assessment (5) Unable to speak and read English (6) Uncorrected visual difficulties such that the participant is unable to read and undertake tasks (7) Pregnant (8) Currently taking or have taken regular probiotic supplements within the previous 3 months and unwilling to undertake an 8-week washout (9) Active infection treated by antibiotic therapy at the time of screening (10) Risky alcohol consumption in the previous 3 months, as defined by NHMRC guideline 1 (no more than 10 standard drinks a week and no more than 4 standard drinks on any one day).
Outcome results
None listed