Urine and Stool Analysis in Kidney Stone Disease

NCT01637506 | Unknown DMC

• 1 other identifier: H10-01195
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Urolithiasis

Keywords

urine; stool; kidney stones

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study group

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

Control group

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

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Vancouver, British Columbia, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

De-identified and study coded urine and stool are collected, processed and analysed in the research laboratory.

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Lange, MSc, PhD

  University of British Columbia

  STUDY DIRECTOR

• Ryan F Paterson, MD, FRCS(C)

  University of British Columbia

  STUDY DIRECTOR

• Colin Collins, MA, CA, PhD

  Vancouver Coastal Health

  STUDY DIRECTOR

• Stephane LeBihan, PhD

  Vancouver Prostate Centre

  STUDY DIRECTOR

Central Study Contacts

Olga Arsovska, BSc

CONTACT

604-875-4111; olga.arsovska@ubc.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: July 11, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)