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Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

NCT03752684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-30

Study results available
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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.

Conditions

  • Calcium Oxalate Urolithiasis

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • John Knight, PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2023-04-27
Completion
2025-05-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752684 on ClinicalTrials.gov