Urine and Stool Analysis in Kidney Stone Disease

Urolithiasis Clinical Trial

Official title:

Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01637506
• Other study ID #: H10-01195
• Status: Recruiting
• Start date: July 2012
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: University of British Columbia
• Contact: Olga Arsovska, BSc
• Phone: 604-875-4111
• Email: olga.arsovska[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Locations

Country	Name	City	State
Canada	Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals	The objective of this study is to compare the bacterial flora in the intestine of patients with kidney stones compared to non-stone forming individuals. If there are differences between stone forming and non-stone forming individuals in the content of their bacterial flora, these will also be correlated with levels of metabolites found in the urine that are known risk factors of stone disease. Difference in bacterial intestinal flora already exists for patients who are obese compared to non-obese individuals.	one day of urine and stool collection