Urine and Stool Analysis in Kidney Stone Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01637506 |
|
Recruitment Status :
Recruiting
First Posted : July 11, 2012
Last Update Posted : November 2, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Urolithiasis |
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 |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease |
| Study Start Date : | July 2012 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
| Group/Cohort |
|---|
Study group
|
Control group
|
- 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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 19 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637506
| 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 | |
| Study Director: | Stephane LeBihan, PhD | Vancouver Prostate Centre |
| Responsible Party: | Ben Chew, MD, Associate Professor, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01637506 |
| Other Study ID Numbers: |
H10-01195 |
| First Posted: | July 11, 2012 Key Record Dates |
| Last Update Posted: | November 2, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
urine stool kidney stones |
|
Urolithiasis Urologic Diseases |