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Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT02739919
Collaborator
(none)
6
Enrollment
1
Location
8.8
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Jun 1, 2016
    Actual Primary Completion Date :
    Feb 23, 2017
    Actual Study Completion Date :
    Feb 24, 2017

    Outcome Measures

    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). [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Stone Centre, VGH/UBC Vancouver British Columbia Canada V5Z 1M9

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    • Principal Investigator: Dirk Lange, MSc, PhD, University of British Columbia
    • Study Director: Ben H Chew, MD, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dirk Lange, Assistant Professor, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT02739919
    Other Study ID Numbers:
    • H16-00637
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    May 2, 2018
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dirk Lange, Assistant Professor, University of British Columbia
    Kidney stones
    Renal Calculi
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis
    Urolithiasis

    Study Results

    No Results Posted as of May 2, 2018