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.
Individuals with ALS-FTDSD, their caregivers and healthy individuals can participate in this randomized, double-blind, parallel, placebo-controlled study. Participants will be enrolled for a period of 32 weeks, with an intervention period of 24 weeks. For ALS-FTDSD participants, there will be 9 visits during the intervention (5 in-person and 4 phone calls) and 1 follow-up call post-intervention. For healthy participants, there will be 4 in-person visits. For all participants, in-person visits will involve filling out questionnaires, giving blood samples, and returning stool samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
150
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
RECRUITINGChange 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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
Change in fecal microbiota in ALS-FTDSD patients
To compare the fecal microbiota composition, diversity, and strain recovery over the 24 weeks of intervention in the probiotic and placebo groups. Techniques will be based on the extraction of DNA and amplification of 16S ribosomal RNA genes. These genes are highly conserved between bacterial species, but vary in a manner that allows species identification.
Time frame: 24 weeks
Lipidomic profiles of healthy participants
To explore lipidomic profiles from baseline in healthy participants over the 24 weeks of intervention. This will be a lipid profiling and quantification by using mass-spectrometry-based lipidomics. We are going to test 900 different lipids, which can be classified in 20 classes ans subclasses of interest.
Time frame: 24 weeks
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