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Bacteria Therapy

Gut Bacteria for Kidney Stones

N/A
Recruiting
Led By Sonia Fargue, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if having a specific type of bacteria in the gut, called Oxalobacter formigenes, can help reduce the amount of a substance called oxalate in the urine

Who is the study for?
Adults with a history of calcium oxalate kidney stones who currently do not have the gut bacteria Oxalobacter formigenes. Participants will need to follow strict diets and provide urine, blood, and stool samples.
What is being tested?
The trial is testing whether introducing Oxalobacter formigenes into patients can lower urinary oxalate levels. It involves fixed diets with varying oxalate levels before and after colonization with the bacteria.
What are the potential side effects?
Potential side effects are not specified but may include digestive discomfort due to diet changes or reactions to bacterial colonization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in urinary oxalate excretion following colonization with Oxalobacter formigenes
Secondary study objectives
Sustainability of colonization with Oxalobacter formigenes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: colonization with Oxalobacter formigenesExperimental Treatment5 Interventions
Colonization with a live preparation of Oxalobacter formigenes, strain OxCC13.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,344 Total Patients Enrolled
13 Trials studying Kidney Stones
738 Patients Enrolled for Kidney Stones
University of Texas Southwestern Medical CenterOTHER
1,083 Previous Clinical Trials
1,058,149 Total Patients Enrolled
5 Trials studying Kidney Stones
752 Patients Enrolled for Kidney Stones
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,379 Total Patients Enrolled
7 Trials studying Kidney Stones
618 Patients Enrolled for Kidney Stones
~27 spots leftby Dec 2030
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