Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
- Conditions
- Calcium Oxalate Urolithiasis
- Registration Number
- NCT03752684
- Lead Sponsor
- University of Alabama at Birmingham
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Good health as judged from a medical history and reported medications
- Not colonized with O. formigenes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes 4 days Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization
- Secondary Outcome Measures
Name Time Method Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes 4 days Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization
Related Research Topics
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Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States