Effects of a probiotic intervention on cognitive symptoms and gut-brain biomarkers in multiple sclerosis (MS); a pilot study.
Type of Study/Intervention
Form of MS
Relapsing remitting MS, Secondary progressive MS
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 and Secondary Progressive 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.
(1) A diagnosis of clinically definite Relapsing Remitting MS, as defined by the McDonald criteria (as diagnosed by their treating neurologist).
(2) A diagnosis of clinically definite Secondary Progressive MS (as diagnosed by their treating neurologist) AND currently taking a disease modifying therapy of any kind
(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.
(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
(8) Currently taking or have taken regular probiotic supplements within the previous 3 months.
(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).
Anticipated start date
No longer recruiting
Ms Terry Purton
School of Psychological Sciences
College of Health and Medicine
University of Tasmania
Phone: +61 3 6324 3129