Urine and Stool Analysis in Kidney Stone Disease
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | December 13, 2011 | ||||||||||||||||
| Last Updated Date | July 10, 2012 | ||||||||||||||||
| Start Date ICMJE | July 2012 | ||||||||||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01637506 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Urine and Stool Analysis in Kidney Stone Disease | ||||||||||||||||
| Official Title ICMJE | Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease | ||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: De-identified and study coded urine and stool are collected, processed and analysed in the research laboratory. |
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| 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. |
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| Condition ICMJE | Urolithiasis | ||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: CONTROLS
STUDY (Stone Patient)
Exclusion Criteria:
CONTROLS ONLY
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| Gender | Both | ||||||||||||||||
| Ages | 19 Years to 90 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01637506 | ||||||||||||||||
| Other Study ID Numbers ICMJE | H10-01195 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | University of British Columbia | ||||||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||||||
| Verification Date | July 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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