O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Summary

The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease.

The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes.

Participants will

* ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time
* collect urine, blood and stool samples during the fixed diets
* ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes

Conditions

• Kidney Stone
• Kidney Calculi
• Urolithiasis
• Urolithiasis, Calcium Oxalate
• Nephrolithiasis
• Nephrolithiasis, Calcium Oxalate
• Oxalate Urolithiasis
• Oxaluria

Interventions

DIETARY_SUPPLEMENT

Low oxalate fixed diets pre-colonization

4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Moderately high oxalate fixed diets pre-colonization

4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Colonization with Oxalobacter formigenes

Ingestion of live Oxalobacter formigenes

DIETARY_SUPPLEMENT

Low oxalate fixed diets post-colonization

4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)

DIETARY_SUPPLEMENT

Moderately high oxalate fixed diets post-colonization

4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  collaborator OTHER

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

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Sonia Fargue, PhD · University of Alabama at Birmingham

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2030-12-31

Completion

2031-12-31

Countries

• United States

Study Locations