Clinical Trials

Effects of a probiotic intervention on cognitive symptoms and gut-brain biomarkers in multiple sclerosis (MS); a pilot study.

Type of Study/Intervention

Interventional

Recruitment Status

Not recruiting

Form of MS

Relapsing remitting MS

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.

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).

Anticipated start date

Mid June 2022

Recruitment contacts

Ms Terry Purton
School of Psychological Sciences
College of Health and Medicine
University of Tasmania
Phone: +61 3 6324 3129
Email: terry.purton@utas.edu.au

Further details

Further details can be found here.

Region

TAS

Ethics approval

Yes

Last updated

18/05/2022

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