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RECRUITING
NCT06330246
NA

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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

Official title: Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-04-17

Completion Date

2031-12-31

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Low oxalate fixed diets pre-colonization

4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Moderately high oxalate fixed diets pre-colonization

4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Colonization with Oxalobacter formigenes

Ingestion of live Oxalobacter formigenes

DIETARY_SUPPLEMENT

Low oxalate fixed diets post-colonization

4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Moderately high oxalate fixed diets post-colonization

4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)

Locations (2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UTSW

Dallas, Texas, United States