- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142101
Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease
Gut Microbiota of Renal Patients
Study Overview
Status
Conditions
Detailed Description
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.
Objectives
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years.
- Patients with PKD.
- Patients are able to understand and give consent.
Exclusion Criteria:
- Patient on antibiotics or vitamin supplement (except vitamin D analogs) in the last three months.
- Advanced liver disease, advanced cardiovascular disease, heart failure with EF < 30%, and autoimmune disease.
- The use of chemotherapy, antibiotics, immunosuppressive medications, probiotics, and steroid in the last three month.
- Intravenous or oral iron supplementation, laxatives, and kayexalate in the last month.
- History of intra abdominal surgery, small or large intestine resection or small bowel obstruction.
- History of colon cancer or gastrointestinal bleed.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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GFR >60
5 patients with polycystic kidney disease with eGFR > 60 ml/min.
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GFR 15-60
5 patients with polycystic kidney disease with eGFR between 15-60 ml/min.
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GFR <15
5 patients with polycystic kidney disease with eGFR <15 ml/min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome sequencing and diversity and its correlation with renal function
Time Frame: at 2 weeks
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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.
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at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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at 2 weeks
|
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.
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at 2 weeks
|
Vit D level
Time Frame: at 2 weeks
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The correlation of Vit D level with gut bacterial population, and its effects on urine and serum metabolites.
|
at 2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: John C He, MD, PhD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 13-1798
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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