Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Calcium Oxalate Urolithiasis Clinical Trial

Official title: Oxalobacter Formigenes Colonization and Oxalate Excretion in Calcium Oxalate Kidney Stone Disease

Status Active, not recruiting

Clinical Trial 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 human subjects and to determine whether this influences the oxalate passed in urine of healthy volunteers.

Clinical Trial 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, a complete metabolic profile of their serum, and ranges of ions that influence stone formation in two 24-hour urine collections, will be recruited from within the greater Birmingham area. Recruited subjects will be between the ages of 18 to 65 years and with a BMI >19 and <32. Subjects not colonized with O. formigenes will consume, firstly, a controlled diet containing 50 mg oxalate and 1000mg calcium (low oxalate/normal calcium diet), followed by a 250 mg oxalate/400mg calcium controlled diet (moderately high oxalate/low calcium diet), with at least a one week washout between each diet, and then repeat the same sequence of diets after colonization with O.formigenes Group 1 strain OxCC13. 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. ;

Related Conditions & MeSH terms

• Calcium Oxalate Urolithiasis
• Urolithiasis

• NCT number: NCT03752684
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2018
• Completion date: December 31, 2024