Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT04087213 - Study of HemoCareā„¢ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD N/A
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Completed NCT02237521 - The Effect of the Incretin Hormones on the Endocrine Pancreatic Function During Hyperglycemia in End-stage Renal Disease N/A
Withdrawn NCT01691196 - Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
Completed NCT01394341 - Liraglutide Treatment to Patients With Severe Renal Insufficiency Phase 4
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4
Completed NCT00307463 - Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation Phase 4
Recruiting NCT00155363 - Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis Phase 4
Completed NCT00234156 - The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers N/A
Completed NCT00586131 - Arterial pH and Total Body Nitrogen Balances in APD Phase 4
Active, not recruiting NCT05027074 - Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) Phase 2
Recruiting NCT04575077 - The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
Enrolling by invitation NCT05001009 - Goals of Care Conversations Study N/A
Completed NCT01756508 - Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury Phase 2
Recruiting NCT03862859 - The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis Phase 4
Terminated NCT03661229 - Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device N/A
Completed NCT03288922 - Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF N/A
Completed NCT02360748 - A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients N/A
Not yet recruiting NCT02238093 - Cardiorenal Syndrome in End-Stage Kidney Disease N/A