Trial record 17 of 97 for:    polycystic kidney disease

Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02142101
First received: May 7, 2014
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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).


Condition
Polycystic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gut Microbiota of Renal Patients

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
GFR >60
5 patients with polycystic kidney disease with eGFR > 60 ml/min.
GFR 15-60
5 patients with polycystic kidney disease with eGFR between 15-60 ml/min.
GFR <15
5 patients with polycystic kidney disease with eGFR <15 ml/min.

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

  1. To compare the gut microbiota in fecal samples of PKD patients with different degrees of renal disease.
  2. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

o All subjects with diagnosis for cystic kidney disease, who were evaluated at Mount Sinai Hospital, Renal clinic, Internal Medicine Associates clinic and Faculty Practice Associates clinics will be identified via the electronic medical system (EPIC).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02142101

Contacts
Contact: Peter Y Chuang, MD 212-241-8004 peter.chuang@mssm.edu
Contact: Rabi Yacoub, MD 212-241-8004 rabi.yacoub@mountsinai.org

Locations
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    rabi.yacoub@mountsinai.org   
Contact: Jonathan Lin, MD    21-241-8004    jonathan.lin@mountsinai.org   
Principal Investigator: John C He, MD, PhD         
Sub-Investigator: Rabi Yacoub, MD         
Sub-Investigator: Jonathan Lin, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: John C He, MD, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02142101     History of Changes
Other Study ID Numbers: GCO 13-1798
Study First Received: May 7, 2014
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Gut Microbiota
Polycystic kidney disease
Chronic kidney disease
Uremic metabolites

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014