Actively Recruiting
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Led by University of Alabama at Birmingham · Updated on 2025-05-13
40
Participants Needed
2
Research Sites
402 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
University of Texas Southwestern Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 70 years
- Body Mass Index greater than 18.5 kg/m2
- First time or recurrent calcium oxalate kidney stone former with most recent stone having at least 50% calcium oxalate if available
- Not colonized with Oxalobacter formigenes
- Normal fasting serum electrolytes on comprehensive metabolic profile
- Willing to follow fixed diets
- Willing to stop supplements (including vitamins, calcium, minerals, herbal supplements, probiotics) for 2 weeks before and during fixed diet phases
- Stable dose of stone prevention medications (e.g., thiazides, citrate, allopurinol) for at least 2 weeks prior to and during the study if applicable
You will not qualify if you...
- Chronic kidney disease stage 4 or 5
- Primary hyperoxaluria
- Liver, endocrine, or renal diseases other than idiopathic calcium oxalate kidney stones or other conditions affecting ion absorption or excretion (including cystic fibrosis, cystinuria, uric acid stones, nephrotic syndrome, sarcoidosis, renal tubular acidosis, primary hyperparathyroidism, neurogenic bladder, urinary diversion)
- Pregnancy or breastfeeding
- Dietary restrictions incompatible with study diets, food allergies or intolerances to study foods
- Active cancer or cancer treatment within 12 months prior to screening
- Use of immunosuppressive medication
- Uncontrolled hypertension or diabetes
- Type 1 diabetes
- Current colonization with Oxalobacter formigenes
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
UTSW
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Sonia Fargue, PhD
CONTACT
D
Demond Wiley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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