Gut Microbiome and p-Inulin in Hemodialysis

End-Stage Renal Disease Clinical Trial

Official title: A Multi-center Study to Characterize the Gut Microbiome of Individuals With End-stage Renal Disease Treated With Maintenance Hemodialysis, and to Explore Effects of P-inulin on the Gut Microbiome

Status Completed

Clinical Trial Summary

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

Clinical Trial Description

This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. The study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. Secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules. ;

Related Conditions & MeSH terms

• Dysbiosis
• End-Stage Renal Disease
• Gut Microbiome Dysbiosis
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT02572882
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Completion date: January 2019