University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT03752684
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.
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Notify Me19 year–65 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be instructed to ingest a controlled diet moderately high in oxalate before colonization
Subjects will ingest live preparation of O. formigenes
Subjects will be instructed to ingest a controlled diet moderately high in oxalate after colonization
Time frame: 4 days
Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization
Time frame: 4 days
Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization
University of Alabama at Birmingham
Other
Oxalobacter Formigenes Colonization and Oxalate Excretion in Healthy Adults
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