O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alabama at Birmingham

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Low oxalate fixed diets pre-colonization
  • Moderately high oxalate fixed diets pre-colonization
  • Colonization with Oxalobacter formigenes
  • Low oxalate fixed diets post-colonization
  • Moderately high oxalate fixed diets post-colonization

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

University of Texas Southwestern Medical Center

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator