NCT03752684

Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Oxalobacter Formigenes Colonization and Oxalate Excretion in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of healthy participants and to determine whether this influences the oxalate passed in urine.

Detailed description

Adults that are not colonized with O. formigenes, have no history of stone disease, and are in good health as judged by their medical history and a complete metabolic profile of their serum, will be recruited from within the greater Birmingham area. Participants not colonized with O. formigenes will consume a controlled diet containing moderately high levels of oxalate (210-240 mg per day), and low levels of calcium (500 - 700 mg per day) and collect 24-hour urines to measure oxalate excretion. Following completion of urine collections, participants will ingest live O.formigenes and one week later stool will be provided to test for colonization with O.formigenes. Participants that are successfully colonized with O.formigenes will then repeat 24 hour urine collections on the same high oxalate, low calcium diet. Controlled diets will be prepared in the Metabolic Kitchen of the UAB Clinical Research Unit (CRU). Sustainability of colonization will be determined over time. Loss of colonization will be confirmed by having the subject consume an oxalate-rich meal with subsequent testing for O. formigenes.

Conditions

• Calcium Oxalate Urolithiasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Moderately high oxalate/low calcium diet non-colonized	Subjects will be instructed to ingest a controlled diet moderately high in oxalate before colonization
DIETARY_SUPPLEMENT	Oxalobacter formigenes	Subjects will ingest live preparation of O. formigenes
DIETARY_SUPPLEMENT	Moderately high oxalate/low calcium diet colonized	Subjects will be instructed to ingest a controlled diet moderately high in oxalate after colonization

Timeline

• Start date: 2018-04-02
• Primary completion: 2023-04-27
• Completion: 2025-05-22
• First posted: 2018-11-26
• Last updated: 2026-01-30
• Results posted: 2025-06-10

Locations

1 site across 1 country: United States