Urine and Stool Analysis in Kidney Stone Disease

This study is currently recruiting participants.
Verified July 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01637506
First received: December 13, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to add to the investigators' quest to understanding stone disease, by evaluating the metabolites excretion in urine and its relation to microflora present in the stool.


Condition
Urolithiasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals [ Time Frame: one day of urine and stool collection ] [ Designated as safety issue: No ]
    The objective of this study is to compare the bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals. If there are differences between stone forming and non-stone forming individuals in the content of their bacterial flora, these will also be correlated with levels of metabolites found in the urine that are known risk factors of stone disease. Difference in bacterial intestinal flora already exists for patients who are obese compared to non-obese individuals.


Biospecimen Retention:   Samples With DNA

De-identified and study coded urine and stool are collected, processed and analysed in the research laboratory.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
  • Age > 19
  • Radiological evidence indicating presence of a current renal or ureteric stone
Control group
  • Age > 19.
  • No history of kidney stone disease

Detailed Description:

Kidney stones affect up to 10% of the Canadian population and can lead to pain, hospitalization, lost of time at work, and surgery. Approximately 80% of stones consist of calcium and oxalate, of which both components come from diet and normal bodily processes. Individuals who have high levels of oxalate in their urine have a greater tendency to generate stones. One recommendation is to reduce their intake of oxalate-containing foods, but many healthy foods contain oxalate, and an oxalate-free diet is unpalatable and difficult to achieve. Some patients, despite reducing their oxalate intake, still have high amounts in the urine.

Intestinal metabolism is largely affected by the state and composition of the intestinal bacterial flora, with several metabolic diseases being linked to a disrupted "normal" intestinal flora. The investigators believe that calcium oxalate stone disease as well as high urinary levels of oxalate (hyperoxaluria) are triggered by inefficient oxalate metabolism in the intestine, which is linked to a "disrupted" intestinal bacterial flora that lacks certain key components such as O. formigenes. The long-term purpose of this study is therefore, to determine the effect of replenishing the intestinal flora of patients with that of "normal" controls, thereby re-introducing a balanced environment that will lead to the re-establishment of normal metabolic functions and a decrease in urinary oxalate levels and hopefully lower incidence of stone disease.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects in the study group are seen at Vancouver General Hospital for their kidney stone disease. Subjects in the control group do not have history or family history of kidney stones and can join the study if they are eligible, wiling to participate, and can provide their specimens at Vancouver General Hospital.

Criteria

Inclusion Criteria:

CONTROLS

  • Age > 19.
  • No history of kidney stone disease

STUDY (Stone Patient)

  • Age > 19
  • Radiological evidence indicating presence of a current renal or ureteric stone

Exclusion Criteria:

  • Pregnancy
  • Positive Urine Culture
  • Active cancer
  • Recurrent urinary infections
  • Gross hematuria
  • Inability to provide informed consent
  • In the Investigator's opinion, the patient would not be good for the study.

CONTROLS ONLY

  • Family history of kidney stones
  • History of kidney stones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637506

Contacts
Contact: Olga Arsovska, BSc 604-875-4111 ext 62421 olga.arsovska@ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska, BSc    604-875-4111 ext 62421    olga.arsovska@ubc.ca   
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion Recruiting
Vancouver, British Columbia, Canada
Contact: Olga Arsovska, BSc    604-875-4111 ext 62421    olga.arsovska@ubc.ca   
Principal Investigator: Ben Chew, MD,MSc,FRCSC         
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: Dirk Lange, MSc, PhD University of British Columbia
Study Director: Ryan F Paterson, MD, FRCS(C) University of British Columbia
Study Director: Colin Collins, MA, CA, PhD Vancouver Coastal Health Authority
Study Director: Stephane LeBihan, PhD Vancouver Prostate Centre
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01637506     History of Changes
Other Study ID Numbers: H10-01195
Study First Received: December 13, 2011
Last Updated: July 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
urine
stool
kidney stones

Additional relevant MeSH terms:
Kidney Calculi
Urolithiasis
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014