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O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT06330246

Registry updated: 2026-10-13

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Description

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

Interventions

Low oxalate fixed diets pre-colonization (Dietary supplement)
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 (Dietary supplement)
4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Colonization with Oxalobacter formigenes (Dietary supplement)
Ingestion of live Oxalobacter formigenes
Low oxalate fixed diets post-colonization (Dietary supplement)
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 (Dietary supplement)
4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)

Eligibility criteria

Inclusion Criteria * 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 * Normal fasting serum electrolytes on comprehensive metabolic profile * Willing to ingest fixed diets * Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during fixed diet phases. * If on medications for stone prevention (e.g. thiazides, citrate, allopurinol), stable dose regimen for at least 2 weeks prior to and during study Exclusion Criteria * 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 * Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus * Active malignancy or treatment for malignancy within 12 months prior to screening * Utilization of immunosuppressive medication * Uncontrolled Hypertension or diabetes * Diabetes type 1 * Current Colonization with Oxalobacter formigenes

Conditions

Kidney Stone Kidney Calculi Urolithiasis Urolithiasis, Calcium Oxalate Nephrolithiasis Nephrolithiasis, Calcium Oxalate Oxalate Urolithiasis Oxaluria

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States
UTSW — Dallas, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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