Clinical Trial: Gut Microbiome and p-Inulin in Hemodialysis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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
Brief Summary: The Microbiome trial is a non-randomized, open-label, crossover, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.
Detailed Summary: This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin 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.
Sponsor: University of Pennsylvania
Current Primary Outcome: Within Participant, Within Phase Variability in Relative Abundance of Metabolites (Efficacy Outcome) [ Time Frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) ]
Microbiome characterization endpoints are within-participant variability in the metabolomic profile and targeted metabolites / inflammatory markers.
Stool samples will be collected at baseline, once weekly during weeks 1-7, 10-19, and 22-28, and twice weekly during weeks 8, 9, 21 and 21. Stool samples will be compared longitudinally within individual subjects, and between groups.
Metabolomic evaluation: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Between Phase Relative Abundance of Metabolites and Bacterial Taxa (Efficacy Outcome) [ Time Frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) ]
Within-participant change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment
Metabolomic evaluation: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
- Within Participant Variability of Bacterial Taxa (Efficacy Outcome) [ Time Frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) ]
Within-participant variability in the bacterial composition of the stool during the no treatment and treatment phases
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
- Between Phase Relative Abundance of Bacterial Taxa (Efficacy Outcome) [ Time Frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) ]
Within-participant change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
- Relative Abundance of Metabolites Between Diabetic and Non-diabetic Patients (Efficacy Outcome) [ Time Frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) ]
Differences in the overall microbiome composition between diabetic and non-diabetic participants
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
- Variability of Metabolites and Bacterial Taxa During the No Treatment Phase (Efficacy Outcome) [ Time Frame: 28 weeks ]
Within-study cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase
Metabolomic evaluation: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
- Variability of Metabolites and Bacterial Taxa During the Treatment Phase (Efficacy Outcome) [ Time Frame: 12 weeks ]
Within-study cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the p-inulin treatment phase
Metabolomic evaluation: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
- Comparison of Variability of Metabolites and Bacterial Taxa During the Treatment/No Treatment Phase (Efficacy Outcome) [ Time Frame: 28 weeks ]
Within-study cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment
Metabolomic evaluation: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
Microbiota evaluation: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
- Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome) [ Time Frame: 28 weeks ]-Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)
- Number of Participants Who Discontinue Use of p-inulin (T
Original Secondary Outcome: Same as current
Information By: University of Pennsylvania
Dates:
Date Received: August 19, 2015
Date Started: October 2015
Date Completion: June 2018
Last Updated: December 9, 2016
Last Verified: December 2016
