Clinical trial NCT01637506: Urine and Stool Analysis in Kidney Stone Disease
Official title: Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urolithiasis
Keywords: urine
stool
kidney stones
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals
timeFrame: one day of urine and stool collection
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Dirk Lange, MSc, PhD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Ryan F Paterson, MD, FRCS(C)
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Colin Collins, MA, CA, PhD
role: STUDY_DIRECTOR
affiliation: Vancouver Prostate Centre
name: Stephane LeBihan, PhD
role: STUDY_DIRECTOR
References: