RecruitingNot ApplicableNCT06330246

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers


Sponsor

University of Alabama at Birmingham

Enrollment

40 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Colonization with Oxalobacter formigenes, Low oxalate fixed diets post-colonization, and others for people with kidney calculi, kidney stone, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTLow oxalate fixed diets pre-colonization

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

DIETARY_SUPPLEMENTModerately 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_SUPPLEMENTColonization with Oxalobacter formigenes

Ingestion of live Oxalobacter formigenes

DIETARY_SUPPLEMENTLow oxalate fixed diets post-colonization

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

DIETARY_SUPPLEMENTModerately 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

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NCT06330246


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