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
age 19-80 yrs
Body Mass Index > 18.5 kg/m2
First time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available
Not colonized with Oxalobacter formigenes
Chronic Kidney Disease stage 4-5
Primary hyperoxaluria
Liver, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion
Pregnancy or breast-feeding
Sequential
Low oxalate fixed diets pre-colonization
Dietary supplement4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
Moderately high oxalate fixed diets pre-colonization
Dietary supplement4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Colonization with Oxalobacter formigenes
Dietary supplementIngestion of live Oxalobacter formigenes
Low oxalate fixed diets post-colonization
Dietary supplement4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
Moderately high oxalate fixed diets post-colonization
Dietary supplement4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Change in urinary oxalate excretion following colonization with Oxalobacter formigenes
Difference between urinary oxalate excretion on the moderately high oxalate diet pre-colonization and urinary oxalate excretion on the moderately high oxalate diet post-colonization
Sustainability of colonization with Oxalobacter formigenes
duration of colonization after successful induction of colonization sith Oxalobacter formigenes
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University of Alabama at Birmingham
Lead sponsor
University of Texas Southwestern Medical Center
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
