Investigating how the gut absorbs 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 clinical trial aims to determine if patients with idiopathic calcium oxalate kidney stones absorb more dietary oxalate, leading to increased urinary oxalate excretion. The study will recruit both kidney stone patients and healthy volunteers, who will follow controlled low and high oxalate diets for five days. Participants will undergo a 13C2-oxalate absorption test to measure gut permeability, with urine, blood, stool, and breath samples collected throughout the study. The goal is to better understand the relationship between dietary oxalate absorption and kidney stone formation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age 18-80 yrs
* Body Mass Index \> 18.5 kg/m2
* 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 study.
* For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available, uric acid component \<20%

Exclusion Criteria:

* Chronic Kidney Disease stage 4-5
* Primary hyperoxaluria, Enteric (secondary) hyperoxaluria
* Liver, bowel, 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, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease
* 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
* Chronic NSAID use

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@uabmc.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.