Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Not Applicable

Active, not recruiting

Interventions: Other: Oxalobacter formigenes
Other: Low Oxalate Diet
Other: Moderately high oxalate/low calcium diet

Brief 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.

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, 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

History of any hepatic, renal, bowel or endocrine disease or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results
colonized with O. formigenes
abnormal urine chemistries or blood metabolic profiles

Arm && Interventions

Group	Intervention	Description
Oxalobacter formigenes	Oxalobacter formigenes	Subjects will ingest a live preparation of O.formigenes
Low Oxalate Diet	Low Oxalate Diet	Subjects not colonized with Oxalobacter formigenes will be equilibrated to a low oxalate diet to determine baseline oxalate values in urine . Subjects will be colonized with Oxalobacter formigenes (Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.
Moderately high oxalate/low calcium diet	Moderately high oxalate/low calcium diet	Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate diet to enhance dietary oxalate absorption. Subjects will be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.

Primary Outcome Measures

Name	Time	Method
Measurement of urinary oxalate by ion chromatography mass spectrometry	4th 24 hour urine collection	96 hours post diet

Secondary Outcome Measures

Name	Time	Method
Measurement of stool oxalate by ion chromatography mass spectrometry	Stool collected 48-96 hours post diet	Third bowel movement collected during days 2 through 4 of dietary control

Locations (1): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States

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