Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT02142101|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : January 5, 2016
|Condition or disease|
|Polycystic Kidney Disease|
Studies have shown that gut microbes can influence numerous aspects of human biology, and alterations in the function and composition of gut microbial flora (microbiota) play a major role in the pathogenesis of diverse human illnesses such as chronic inflammation, diabetes mellitus, and cardiovascular diseases. Gut microbes provide protection against pathogenic organisms, contribute to energy metabolism, serve a clear role in the development and modulation of the human gut immune system, and participate in nitrogen and micronutrient homeostasis by synthesizing amino acids and various vitamins. However, whether the composition of gut microbes is altered in human with renal failure has not been clearly demonstrated. Furthermore, whether alterations in the gut microbiota due to renal failure contribute to development of co-morbid conditions associated with CKD has never been examined. There are several lines of evidence to suggest that the gut microbiota is likely altered in patients with CKD. It has been established that protein assimilation in the small intestine is impaired in CKD .
To examine the impact of renal failure on the composition of gut microbiota we are studying patients with renal failure due to polycystic kidney disease (PKD). PKD is the fourth leading cause of kidney failure, and is the most common genetic kidney disease. Compared to patients with renal failure due to diabetic nephropathy, hypertension, and glomerulonephritis, patients with PKD have virtually no major co-morbid medical conditions or associated medical interventions (i.e. antimicrobial or anti-inflammatory therapies) that could potentially alter the gut microbiota, and confound the interpretation of data.
- To compare the gut microbiota in fecal samples of PKD patients with different degrees of renal disease.
- To determine whether alteration in the composition of gut microbiota is linked to serum levels of metabolites and uremic solutes that are known to be associated with symptoms of uremia.
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Gut Microbiota of Renal Patients|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
5 patients with polycystic kidney disease with eGFR > 60 ml/min.
5 patients with polycystic kidney disease with eGFR between 15-60 ml/min.
5 patients with polycystic kidney disease with eGFR <15 ml/min.
- Microbiome sequencing and diversity and its correlation with renal function [ Time Frame: at 2 weeks ]The diversity of gut bacterial population and its correlation with the renal function, bacterial DNA extract will be sequenced using MiSeq. Data will be analyzed using QiiMe program.
- Uremic metabolites and its correlation with gut microbiota [ Time Frame: at 2 weeks ]To evaluate the uremic metabolites and its association with specific bacterial phylum identified by bacterial DNA sequencing
- Kidney function and uremic metabolites [ Time Frame: at 2 weeks ]To evaluate the correlation of uremic metabolites in urine and its correlation with renal function by analyzing non-targeted metabolite profiling platform.
- Vit D level [ Time Frame: at 2 weeks ]The correlation of Vit D level with gut bacterial population, and its effects on urine and serum metabolites.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142101
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||John C He, MD, PhD||Icahn School of Medicine at Mount Sinai|