Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01637506
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2011-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine and Stool Analysis in Kidney Stone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'De-identified and study coded urine and stool are collected, processed and analysed in the research laboratory.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['urine', 'stool', 'kidney stones'], 'conditions': ['Urolithiasis']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nIntestinal 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nControls\n\n* Age \\> 19.\n* No history of kidney stone disease\n\nStudy Patient (Stone Patient)\n\n* Age \\> 19\n* Radiological evidence indicating presence of a current renal or ureteric stone\n\nExclusion Criteria:\n\n* Pregnancy\n* Positive Urine Culture\n* Active cancer\n* Recurrent urinary infections\n* Gross hematuria\n* Inability to provide informed consent\n* In the Investigator's opinion, the patient would not be good for the study.\n\nControls Only:\n\n* Family history of kidney stones\n* History of kidney stones"}, 'identificationModule': {'nctId': 'NCT01637506', 'briefTitle': 'Urine and Stool Analysis in Kidney Stone Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Correlation Between Excretion Metabolites in Urine and Bacterial Microflora in Patients With Urinary Stone Disease', 'orgStudyIdInfo': {'id': 'H10-01195'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '* Age \\> 19\n* Radiological evidence indicating presence of a current renal or ureteric stone'}, {'label': 'Control group', 'description': '* Age \\> 19.\n* No history of kidney stone disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olga Arsovska, BSc', 'role': 'CONTACT', 'email': 'olga.arsovska@ubc.ca', 'phone': '604-875-4111', 'phoneExt': '62421'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olga Arsovska, BSc', 'role': 'CONTACT', 'email': 'olga.arsovska@ubc.ca', 'phone': '604-875-4111', 'phoneExt': '62421'}, {'name': 'Ben Chew, MD,MSc,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Olga Arsovska, BSc', 'role': 'CONTACT', 'email': 'olga.arsovska@ubc.ca', 'phone': '604-875-4111', 'phoneExt': '62421'}], 'overallOfficials': [{'name': 'Dirk Lange, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Ryan F Paterson, MD, FRCS(C)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Colin Collins, MA, CA, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vancouver Coastal Health'}, {'name': 'Stephane LeBihan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vancouver Prostate Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ben Chew, MD', 'investigatorAffiliation': 'University of British Columbia'}}}}