Urine and Stool Analysis in Kidney Stone Disease

NCT ID: NCT01637506

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Urolithiasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

* Age \> 19
* Radiological evidence indicating presence of a current renal or ureteric stone

No interventions assigned to this group

Control group

* Age \> 19.
* No history of kidney stone disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Ben Chew, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk Lange, MSc, PhD

Role: STUDY_DIRECTOR

University of British Columbia

Ryan F Paterson, MD, FRCS(C)

Role: STUDY_DIRECTOR

University of British Columbia

Colin Collins, MA, CA, PhD

Role: STUDY_DIRECTOR

Vancouver Coastal Health

Stephane LeBihan, PhD

Role: STUDY_DIRECTOR

Vancouver Prostate Centre

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Olga Arsovska, BSc

Role: CONTACT

604-875-4111 ext. 62421

Facility Contacts

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Olga Arsovska, BSc

Role: primary

604-875-4111 ext. 62421

Olga Arsovska, BSc

Role: primary

604-875-4111 ext. 62421

Other Identifiers

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H10-01195

Identifier Type: -

Identifier Source: org_study_id

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