UrolithiasisNCT01637506
Urine and Stool Analysis in Kidney Stone Disease
An observational study of Urolithiasis, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2012to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Positive Urine Culture
- Active cancer
- Recurrent urinary infections
- Gross hematuria
- Inability to provide informed consent
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Olga Arsovska, BSc, 604-875-4111 ext. 62421, olga.arsovska@ubc.ca
- Recruiting
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
Vancouver, British Columbia
Olga Arsovska, BSc, 604-875-4111 ext. 62421, olga.arsovska@ubc.ca
Ben Chew, MD,MSc,FRCSC
About this study
Official title: Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease
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.
Read the 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.
- Conditions
- Urolithiasis
- Keywords
- urine, stool, kidney stones
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | * Age > 19 * Radiological evidence indicating presence of a current renal or ureteric stone | |
| Control group | * Age > 19. * No history of kidney stone disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals
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.
Measured: one day of urine and stool collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Dirk Lange, MSc, PhD, Study director, University of British ColumbiaRyan F Paterson, MD, FRCS(C), Study director, University of British ColumbiaColin Collins, MA, CA, PhD, Study director, Vancouver Coastal HealthStephane LeBihan, PhD, Study director, Vancouver Prostate Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637506
- Sponsor's protocol ID
- H10-01195
- Status last verified
- Oct 2022
- First submitted
- 13 Dec 2011
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease
- ClinicalTrials.gov ID
- NCT01637506
- Acronym / sponsor ID
- H10-01195
- Conditions
- Urolithiasis
- Keywords
- urine, stool, kidney stones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –* Age > 19 * Radiological evidence indicating presence of a current renal or ureteric stone |
| Control group | – | –* Age > 19. * No history of kidney stone disease |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Controls
- Age > 19.
- No history of kidney stone disease
- Study Patient (Stone Patient)
- Age > 19
Key exclusion criteria (10 listed)
- Pregnancy
- Positive Urine Culture
- Active cancer
- Recurrent urinary infections
- Gross hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Lange, MSc, PhD study director
University of British Columbia
Ryan F Paterson, MD, FRCS(C) study director
University of British Columbia
Colin Collins, MA, CA, PhD study director
Vancouver Coastal Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Arsovska, BSc (604-875-4111 ext. 62421, olga.arsovska@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.