- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637506
Urine and Stool Analysis in Kidney Stone Disease
Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Olga Arsovska, BSc
- Phone Number: 62421 604-875-4111
- Email: olga.arsovska@ubc.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
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Contact:
- Olga Arsovska, BSc
- Phone Number: 62421 604-875-4111
- Email: olga.arsovska@ubc.ca
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Vancouver, British Columbia, Canada
- Recruiting
- Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
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Contact:
- Olga Arsovska, BSc
- Phone Number: 62421 604-875-4111
- Email: olga.arsovska@ubc.ca
-
Principal Investigator:
- Ben Chew, MD,MSc,FRCSC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study group
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Control group
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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.
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one day of urine and stool collection
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Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-01195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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