UrolithiasisNCT02739919
Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy
An observational study of Urolithiasis, run by University of British Columbia at 1 site in Canada.
Trial summary
The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urolithiasis
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to 24 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Vancouver General Hospital that are diagnosed with a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
Who may be able to join
- Over the age of 18
- Diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
- Medically fit for definitive surgical management of stone
Who cannot join
- Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
- Patients who are unable to provide informed consent.
- 18 years old or younger
- Diagnosed with an infection stone
- Urinary tract infection within 3 months before date of operation
- Antibiotic use within 3 month before date of operation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.
Read the detailed description
Kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. While struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests.
There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. The investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. An understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.
- Conditions
- Urolithiasis
- Keywords
- Kidney stones, Renal Calculi
- Medical subject headings
- Urolithiasis, Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of stone formation in artificial urine with isolated bacteria from non-infection kidney stones compared to control measured using FTIR-Microscopy and SEM (concentration measured in mg/mL).
Bacteria will be isolated from non-infection kidney stones allowed to form a biofilm. Next, the bacteria will be incubated in supersaturated artificial urine to precipitate stone formation in vitro and compared to control urine consisting of the same artificial urine without bacteria. Over time, crystallization in the biofilm will be measured using FTIR-Microscopy and SEM.
Measured: Through study completion, approximately 2 years
Bacteria isolated from non-infection kidney stone compared to those identified on pre-operative urine test quantified by simple serial dilution and CFU counting (measured in CFU/mL) and identified using DNA sequencing.
Bacteria will be quantified using simple serial dilution and CFU counting and identified using DNA sequencing. Bacteria will then be correlated with the bacteria identified on pre-operative urine test.
Measured: Through study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion23 Feb 2017
- Study completion24 Feb 2017
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 only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Lange, University of British Columbia
- Investigators
- Dirk Lange, MSc, PhD, Principal investigator, University of British ColumbiaBen H Chew, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739919
- Sponsor's protocol ID
- H16-00637
- Status last verified
- Nov 2016
- First submitted
- 16 Mar 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT02739919
- Acronym / sponsor ID
- H16-00637
- Conditions
- Urolithiasis
- Keywords
- Kidney stones, Renal Calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 15 Apr 2016 (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 aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.
Detailed description
Kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. While struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests.
There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. The investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. An understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Vancouver General Hospital that are diagnosed with a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
Key inclusion criteria (3 listed)
- Over the age of 18
- Diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
- Medically fit for definitive surgical management of stone
Key exclusion criteria (6 listed)
- Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
- Patients who are unable to provide informed consent.
- 18 years old or younger
- Diagnosed with an infection stone
- Urinary tract infection within 3 months before date of operation
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
Amount of stone formation in artificial urine with isolated bacteria from non-infection kidney stones compared to control measured using FTIR-Microscopy and SEM (concentration measured in mg/mL).
Time frame: Through study completion, approximately 2 years
Bacteria will be isolated from non-infection kidney stones allowed to form a biofilm. Next, the bacteria will be incubated in supersaturated artificial urine to precipitate stone formation in vitro and compared to control urine consisting of the same artificial urine without bacteria. Over time, crystallization in the biofilm will be measured using FTIR-Microscopy and SEM.
Bacteria isolated from non-infection kidney stone compared to those identified on pre-operative urine test quantified by simple serial dilution and CFU counting (measured in CFU/mL) and identified using DNA sequencing.
Time frame: Through study completion, approximately 2 years
Bacteria will be quantified using simple serial dilution and CFU counting and identified using DNA sequencing. Bacteria will then be correlated with the bacteria identified on pre-operative urine test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- 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 principal investigator
University of British Columbia
Ben H Chew, MD study director
University of British Columbia
1 site 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 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of stone formation in artificial urine with isolated bacteria from non-infection kidney stones compared to control measured using FTIR-Microscopy and SEM (concentration measured in mg/mL). (time frame: Through study completion, approximately 2 years). The study lists 2 primary outcomes in all. 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 May 2018.