Urine and Stool Analysis in Kidney Stone Disease
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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 |
- 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
|
Control group
|
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 |
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.
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| Contact: Olga Arsovska, BSc | 604-875-4111 ext 62421 | olga.arsovska@ubc.ca |
| 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 | |
| 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 May 22, 2013