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 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 lipidomic profiles
To compare the change in lipidomic profiles from baseline in the probiotic and placebo groups (within-group) as well as in between-group differences 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
Change in polar metabolite profiles
To compare the change in polar metabolite profiles from baseline in the probiotic and placebo groups (within-group) as well as in between-group differences over the 24 weeks of intervention. Targets will be key microbiota metabolites: trimethylamine N-oxide (TMAO), short-chain fatty acids, and metabolites derived from tryptophan.
Time frame: 24 weeks
Change in ALSFRS-R score
To compare the average change from baseline in the rate of decline in ALS Functional Rating Scale Revised (ALSFRS-R) between the probiotic and placebo groups over the 24 weeks of intervention.
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 FAB 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
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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
Polar metabolite profiles of healthy participants
To explore polar metabolite profiles from baseline in healthy participants over the 24 weeks of intervention. Targets will be key microbiota metabolites: trimethylamine N-oxide (TMAO), short-chain fatty acids, and metabolites derived from tryptophan.
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
Fecal microbiota of healthy participants
Explore the fecal microbiota composition, diversity, and strain recovery over the 24 weeks in the healthy participants. 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