Using gut bacteria to reduce urinary oxalate in kidney stone patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to determine if colonization with the gut bacteria Oxalobacter formigenes can decrease urinary oxalate excretion in adults with calcium oxalate kidney stones. Participants will follow controlled diets with varying oxalate levels and provide urine, blood, and stool samples for analysis. The study will involve a pre-colonization phase with dietary monitoring followed by colonization with live Oxalobacter formigenes. The effectiveness of this intervention will be assessed by measuring changes in urinary oxalate levels.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Utsw
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Sonia Fargue, PhD — University of Alabama at Birmingham
• Study coordinator: Sonia Fargue, PhD
• Email: sfargue@uab.edu
• Phone: 2059756932

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.