Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Calcium Oxalate Urolithiasis
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Evaluate urinary oxalate excretion before and after colonization with the oxalate degrading bacterium Oxalobacter formigenesMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 19 years and 65 years
Gender
Both males and females

Description

Adults that are not colonized with O. formigenes, have no history of stone disease and are in good health as judged by their medical history, a complete metabolic profile of their serum, and ranges of ions that influence stone formation in two 24-hour urine collections, will be recruited from within...

Adults that are not colonized with O. formigenes, have no history of stone disease and are in good health as judged by their medical history, a complete metabolic profile of their serum, and ranges of ions that influence stone formation in two 24-hour urine collections, will be recruited from within the greater Birmingham area. Recruited subjects will be between the ages of 18 to 65 years and with a BMI >19 and <32. Subjects not colonized with O. formigenes will consume, firstly, a controlled diet containing 50 mg oxalate and 1000mg calcium (low oxalate/normal calcium diet), followed by a 250 mg oxalate/400mg calcium controlled diet (moderately high oxalate/low calcium diet), with at least a one week washout between each diet, and then repeat the same sequence of diets after colonization with O.formigenes Group 1 strain OxCC13. Controlled diets will be prepared in the Metabolic Kitchen of the UAB Clinical Research Unit (CRU). Each subject will perform a sodium 13C2-oxalate oral load once at the end of each of the two dietary phases to assess dietary oxalate absorption. Sustainability of colonization will be determined over time. Loss of colonization will be confirmed by having the subject consume an oxalate-rich meal with subsequent testing for O. formigenes.

Tracking Information

NCT #
NCT03752684
Collaborators
Not Provided
Investigators
Principal Investigator: John Knight, PhD University of Alabama at Birmingham