Randomized Study of Probiotics Effects on Lipid Profiles and Disease Progression in Adults with ALS-FTDSD

What this Trial Is About

Researchers are studying the effects of a probiotic supplement on people with Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder ALS-FTDSD. The study aims to see if taking probiotics changes blood lipid profiles compared to a placebo. This is a randomized, double-blind, placebo-controlled trial including both ALS-FTDSD patients and healthy participants, assessing supportive care effects over several months. Participants will be assigned to one of two groups one receiving a probiotic sachet daily for 24 weeks, and the other receiving a placebo sachet daily for the same period. The study includes 9 visits for ALS-FTDSD participants 5 in-person and 4 phone calls and 4 in-person visits for healthy participants. During visits, participants complete questionnaires and provide blood and stool samples. There is also one follow-up call after the intervention ends. Participants will be involved for a total of 32 weeks including the 24-week intervention. Throughout the study, researchers will measure changes in plasma lipids and metabolites, ALS functional scores, cognitive and quality-of-life assessments, neurofilament levels, and gut microbiota. Safety and disease progression are monitored, with follow-up assessments to capture lasting effects of the probiotic compared to placebo.

Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients