Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Texas
UTSW
RECRUITING
Dallas
Contact Information
Primary
Sonia Fargue, PhD
sfargue@uab.edu
2059756932
Backup
Demond Wiley
kidneystone@uabmc.edu
2059345712
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 40
Treatments
Experimental: colonization with Oxalobacter formigenes
Colonization with a live preparation of Oxalobacter formigenes, strain OxCC13.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas Southwestern Medical Center
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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