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Clinical Trials/NCT01637506
NCT01637506
Recruiting
Not Applicable

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

University of British Columbia2 sites in 1 country20 target enrollmentJuly 2012
ConditionsUrolithiasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
University of British Columbia
Enrollment
20
Locations
2
Primary Endpoint
Bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ben Chew, MD

Associate Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Study Sites (2)

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