An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants

一项开放标签、非随机研究,评估了对一小部分帕金森病患者进行益生元纤维干预的效果

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作者:Deborah A Hall #, Robin M Voigt #, Thaisa M Cantu-Jungles, Bruce Hamaker, Phillip A Engen, Maliha Shaikh, Shohreh Raeisi, Stefan J Green, Ankur Naqib, Christopher B Forsyth, Tingting Chen, Richard Manfready, Bichun Ouyang, Heather E Rasmussen, Shahriar Sedghi, Christopher G Goetz, Ali Keshavarzian

Abstract

A pro-inflammatory intestinal microbiome is characteristic of Parkinson's disease (PD). Prebiotic fibers change the microbiome and this study sought to understand the utility of prebiotic fibers for use in PD patients. The first experiments demonstrate that fermentation of PD patient stool with prebiotic fibers increased the production of beneficial metabolites (short chain fatty acids, SCFA) and changed the microbiota demonstrating the capacity of PD microbiota to respond favorably to prebiotics. Subsequently, an open-label, non-randomized study was conducted in newly diagnosed, non-medicated (n = 10) and treated PD participants (n = 10) wherein the impact of 10 days of prebiotic intervention was evaluated. Outcomes demonstrate that the prebiotic intervention was well tolerated (primary outcome) and safe (secondary outcome) in PD participants and was associated with beneficial biological changes in the microbiota, SCFA, inflammation, and neurofilament light chain. Exploratory analyses indicate effects on clinically relevant outcomes. This proof-of-concept study offers the scientific rationale for placebo-controlled trials using prebiotic fibers in PD patients. ClinicalTrials.gov Identifier: NCT04512599.

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