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O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Sponsor: University of Alabama at Birmingham
Summary
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time * collect urine, blood and stool samples during the fixed diets * ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes
Official title: Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-04-17
Completion Date
2031-12-31
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
Low oxalate fixed diets pre-colonization
4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
Moderately high oxalate fixed diets pre-colonization
4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Colonization with Oxalobacter formigenes
Ingestion of live Oxalobacter formigenes
Low oxalate fixed diets post-colonization
4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
Moderately high oxalate fixed diets post-colonization
4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Locations (2)
University of Alabama at Birmingham
Birmingham, Alabama, United States
UTSW
Dallas, Texas, United States