Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease

NCT02142101 | Completed

• 1 other identifier: GCO 13-1798
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Polycystic Kidney Disease

Keywords

Gut Microbiota; Polycystic kidney disease; Chronic kidney disease; Uremic metabolites

Outcome Measures

Primary Outcomes (1)

• Microbiome sequencing and diversity and its correlation with renal function

  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.

  at 2 weeks

Secondary Outcomes (3)

• Uremic metabolites and its correlation with gut microbiota

  at 2 weeks

• Kidney function and uremic metabolites

  at 2 weeks

• Vit D level

  at 2 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age \> 18 years.
• Patients with PKD.
• Patients are able to understand and give consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine will be saved for metabolite analysis; stool will be used to extract bacterial DNA for sequencing.

MeSH Terms

Conditions

Polycystic Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John C He, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 20, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)