Study on the Effects of Inulin Supplementation on Gut Health in Adults with Advanced Chronic Kidney Disease

What this Trial Is About

Researchers are investigating the effects of inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites, and immune cell states in patients with advanced chronic kidney disease undergoing hemodialysis. This randomized, placebo-controlled trial aims to understand how fiber intake impacts these factors, as chronic kidney disease patients often have insufficient dietary fiber. The study is sponsored by Charite University, Berlin, Germany. Participants will receive either inulin or a placebo maltodextrin over a 35-day period. The intervention starts with 15 grams daily for 7 days, followed by 30 grams daily for 28 days. The study design includes a quadruple masking and random allocation to either inulin or placebo groups to assess the effects of the dietary supplement on gut health and kidney disease-related outcomes. During the trial, participants plasma concentration of Zonulin-1 will be measured after 35 days as the primary outcome. Secondary outcomes include various markers such as soluble CD14, gene expression related to short-chain fatty acids and indole in bacteria and immune cells, fecal and serum metabolomes, blood pressure, inflammatory cytokines, kidney function markers, and immune cell frequencies. The total study duration includes these assessments, with ongoing monitoring of safety and adherence throughout the intervention period.

Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease