Status:

RECRUITING

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

University of Texas Southwestern Medical Center

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

Conditions:

Kidney Stone

Kidney Calculi

Eligibility:

All Genders

18-70 years

Phase:

NA

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. ...

Detailed Description

In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, before and after inducing colonization with the gut bacteria Oxa...

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

Key Trial Info

Start Date :

April 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06330246

Start Date

April 17 2024

End Date

December 31 2031

Last Update

May 13 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

UTSW

Dallas, Texas, United States, 75390