Clinical trial NCT03752684: Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
Official title: Oxalobacter Formigenes Colonization and Oxalate Excretion in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcium Oxalate Urolithiasis
Keywords: Oxalobacter formigenes
oxalate
kidney stones
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-11-26
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Evaluate urinary oxalate excretion before and after colonization with the oxalate degrading bacterium Oxalobacter formigenes
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes
timeFrame: 4 days
Secondary outcomes:
measure: Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes
timeFrame: 4 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John Knight, PhD
role: PRINCIPAL_INVESTIGATOR
References: