NCT06330246View on ClinicalTrials.gov

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2031

Conditions
Kidney StoneKidney CalculiUrolithiasisUrolithiasis, Calcium OxalateNephrolithiasisNephrolithiasis, Calcium OxalateOxalate UrolithiasisOxaluria
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)

Trial Locations (2)

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

75390

RECRUITING

UTSW, Dallas

All Listed Sponsors
collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

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

NIH

lead

University of Alabama at Birmingham

OTHER