O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Recruiting now · Not applicable
Conditions studied: Kidney Stone, Kidney Calculi, Urolithiasis, Urolithiasis, Calcium Oxalate, Nephrolithiasis, Nephrolithiasis, Calcium Oxalate, Oxalate Urolithiasis, Oxaluria
In brief
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
Key facts
- Study ID
- NCT06330246
- Run by
- University of Alabama at Birmingham
- People needed
- 40
- Starts
- 2024-04-17
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- UTSW — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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