About this trial
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
Eligibility criteria
Qualifiers
age 19-70 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low oxalate fixed diets pre-colonization
- Moderately high oxalate fixed diets pre-colonization
- Colonization with Oxalobacter formigenes
- Low oxalate fixed diets post-colonization
- Moderately high oxalate fixed diets post-colonization
Treatment groups
Sponsors and collaborators
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