Urine and Stool Analysis in Kidney Stone Disease

October 31, 2022 updated by: Ben Chew, MD, University of British Columbia

Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
        • Contact:
        • Principal Investigator:
          • Ben Chew, MD,MSc,FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

Controls

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

Study Patient (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
one day of urine and stool collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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
  • Study Director: Stephane LeBihan, PhD, Vancouver Prostate Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-01195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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