Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Purpose

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.

Condition

  • Calcium Oxalate Urolithiasis

Eligibility

Eligible Ages
Between 19 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Evaluate urinary oxalate excretion before and after colonization with the oxalate degrading bacterium Oxalobacter formigenes
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Colonization with Oxalobacter formigenes 		Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet
  • Dietary Supplement: Moderately high oxalate/low calcium diet non-colonized
    Subjects will be instructed to ingest a controlled diet moderately high in oxalate before colonization
  • Dietary Supplement: Oxalobacter formigenes
    Subjects will ingest live preparation of O. formigenes
  • Dietary Supplement: Moderately high oxalate/low calcium diet colonized
    Subjects will be instructed to ingest a controlled diet moderately high in oxalate after colonization

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

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.