NCT06330246 O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
| NCT ID | NCT06330246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-17 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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
Contact & Investigator
Sonia Fargue, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06330246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06330246 currently recruiting?
Yes, NCT06330246 is actively recruiting participants. Contact the research team at sfargue@uab.edu for enrollment information.
Where is the NCT06330246 trial being conducted?
This trial is being conducted at Birmingham, United States, Dallas, United States.
Who is sponsoring the NCT06330246 clinical trial?
NCT06330246 is sponsored by University of Alabama at Birmingham. The principal investigator is Sonia Fargue, PhD at University of Alabama at Birmingham. The trial plans to enroll 40 participants.
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