Status:
RECRUITING
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Kidney Stone
Kidney Calculi
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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. ...
Detailed Description
In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, before and after inducing colonization with the gut bacteria Oxa...
Eligibility Criteria
Inclusion Criteria
- 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
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
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06330246
Start Date
April 17 2024
End Date
December 31 2031
Last Update
May 13 2025
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UTSW
Dallas, Texas, United States, 75390