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Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

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ClinicalTrials.gov Identifier: NCT02739919
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dirk Lange, University of British Columbia

Brief 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. 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.

Condition or disease
Urolithiasis

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.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy
Study Start Date : June 2016
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
De-identified and study coded kidney stone and urine samples are collected, processed and analysed in the research laboratory.


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Vancouver General Hospital that are diagnosed with a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT02739919


Locations
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Canada, British Columbia
The Stone Centre, VGH/UBC
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Dirk Lange, MSc, PhD University of British Columbia
Study Director: Ben H Chew, MD University of British Columbia
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Responsible Party: Dirk Lange, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02739919    
Other Study ID Numbers: H16-00637
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dirk Lange, University of British Columbia:
Kidney stones
Renal Calculi
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical