Gut Microbial Remodeling with Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's disease: Safety and Tolerability Study

Emerging evidence has found a relationship between the gastrointestinal system and Parkinson’s disease (PD) pathogenesis. In particular, the colonic microbiome has been found to be altered in PD. The reduced bacteria and associated metabolites may be important for gut function in PD and in PD pathogenesis. Interventions such as dietary modification and probiotics that could alter the gut microbiome have been used but have not assessed the gut microbiome. Resistant maltodextrin (RM) is a prebiotic non-digestible fiber that can alter the gut microbiome in healthy individuals but has not been assessed for safety or efficacy in PD. We propose a randomized, double-blind, parallel group controlled clinical trial assessing RM 50 g daily to the control maltodextrin in people with PD over a 4-week period. We will address the following aims: 1) To determine the safety and tolerability of RM compared to maltodextrin in patients with PD; 2) To determine if RM will remodel the gut microbiome in patients with PD; 3) (exploratory) To determine if RM administration will improve motor and non-motor symptoms in PD. The primary outcome in this study will be safety and tolerability, and the secondary outcome will be alterations in fecal microbiome. Data from this study will inform the viability of RM to be a safe intervention that could alter the gut microbiome and will inform future studies on potential effect sizes for clinical (motor and non-motor) measures.