N/A
N=26
Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
Calcium Oxalate Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT03752684 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes — 14 Percentage decrease in urinary oxalate
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moderately high oxalate/low calcium diet non-colonized (Dietary_supplement); Oxalobacter formigenes (Dietary_supplement); Moderately high oxalate/low calcium diet colonized (Dietary_supplement)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes |
14 | — |
| SECONDARY Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes |
54 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03752684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.