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Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Not Applicable
Completed
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
Inclusion Criteria
  • Good health as judged from a medical history and reported medications
  • Not colonized with O. formigenes
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Primary Outcome Measures
NameTimeMethod
Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes4 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
NameTimeMethod
Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes4 days

Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization

Trial Locations

Locations (1)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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