Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease
Gut microbes can influence numerous aspects of human biology. Alterations in the function and composition of gut microbial flora (gut microbiota ) have been linked to inflammatory bowel disease, chronic inflammation, dyslipidemia, diabetes mellitus, atopic disorders, cardiovascular disease, neoplasms, and obesity. However, little is known whether renal failure alters the composition of gut microbiota and whether an alteration in the gut microbiota of patients with renal failure impacts on the development of co-morbid conditions such as accelerated atherosclerosis, abnormal bone mineral metabolism, and chronic inflammation that are associated with renal failure. Nonetheless, several lines of evidence suggest that renal failure alters the chemical environment of the intestinal lumen, which could impose a selective pressure on the growth of certain gut microbes. The investigators hypothesize that the gut microbiota of patients with renal failure is different from those without renal failure. To test this hypothesis the investigators are conducting a cross-sectional study of gut microbiota in patients with different degrees of renal failure due to polycystic kidney disease (PKD).
Polycystic Kidney Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Gut Microbiota of Renal Patients|
- Microbiome sequencing and diversity and its correlation with renal function [ Time Frame: at 2 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The correlation of Vit D level with gut bacterial population, and its effects on urine and serum metabolites.
Biospecimen Retention: Samples With DNA
Serum and urine will be saved for metabolite analysis; stool will be used to extract bacterial DNA for sequencing.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02142101
|Contact: Peter Y Chuang, MDfirstname.lastname@example.org|
|Contact: Rabi Yacoub, MDemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Rabi Yacoub, MD 212-241-8004 firstname.lastname@example.org|
|Contact: Jonathan Lin, MD 21-241-8004 email@example.com|
|Principal Investigator: John C He, MD, PhD|
|Sub-Investigator: Rabi Yacoub, MD|
|Sub-Investigator: Jonathan Lin, MD|
|Principal Investigator:||John C He, MD, PhD||Mount Sinai School of Medicine|