The aim of this study is to assess the impact of a probiotic formulation on participants with ALS-FTDSD. It is hypothesized that participants given the probiotics will have different lipid profiles compared to participants receiving the placebo at different time points.
Aged 18 years old or greater.
Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with lab support and definite).
Onset of weakness or speech impairment no more than 24 months before randomization.
ALSFRS-R equal or superior to 24/48 at screening, with no more than one subscore under 2/4.
Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screening.
Significant medical condition or behavioral issues that could interfere with participation in the clinical trial in the principal investigator's opinion.
Use of a feeding tube at randomization.
Use of lipid-lowering drugs for less than 3 months before randomization.
Parallel
Probiotic
Dietary supplementParticipants will be taking 1 sachet a day.
Placebo
Dietary supplementParticipants will be taking 1 sachet a day.
Change in lipids and polar metabolites composition in the plasma of participant
Metabolomics will provide a quantitative and qualitative assesment of the lipidomic and polar metabolite profiles of participants on the probiotic arm and the participants on the placebo arm. Participants will be assessed at week 0, at week 12 and then at the end of the investigation period at week 24.
Change in ALS Functional Rating Scale Revised (ALSFRS-R) score
Participants' ALS Functional Rating Scale Revised (ALSFRS-R) score, following intake of the probiotic or placebo. Participants will be assessed at week 0, at week12 and then at the end of the investigation period at week 24.
Change in ALS-CBS score
To compare the average change from baseline in ALS Cognitive Behavioral Screen (ALS-CBS) and Frontal Assessment Battery (FAB) between the probiotic and placebo groups over the 24 weeks of intervention.
Change in neurofilament light chain concentration
To compare the average change from baseline in the neurofilament light chain concentration between the probiotic and placebo groups over the 24 weeks of intervention.
Change in ALSAQ-5 scores
To compare the average change from baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) between the probiotic and placebo groups over the 24 weeks of intervention.
Number of AEs and SAEs
To compare the number of adverse events (AEs) and serious adverse events (SAEs) that occur among to the probiotic group versus the placebo group throughout the study.
Changes in lab safety marker: Complete Blood Count (CBC)
Changes (outside normal variation) in safety lab marker: Complete Blood Count (CBC).
Changes in lab safety markers: Liver Function Test (LFT) - ALT
Changes (outside normal variation) in safety lab markers :Liver Function Tests (LFTs), more precisely alanine transaminase (ALT).
Changes in lab safety markers: Liver Function Test (LFT) - AST
Changes (outside normal variation) in safety lab markers :Liver Function Tests (LFTs), more precisely aspartate transaminase (AST).
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Lallemand Health Solutions
Collaborator
