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Bacterium

Oxalobacter Formigenes for Kidney Stones

N/A

Waitlist Available

Led By John Knight, 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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up stool collected 48-96 hours post diet

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a common gut bacteria can help reduce oxalate in urine.

Who is the study for?

This trial is for healthy individuals who are not currently colonized with the bacterium O. formigenes and have no history of liver, kidney, bowel or endocrine diseases that could affect ion absorption or urinary excretion.

What is being tested?

The study tests if ingesting a small amount of O. formigenes can settle in human guts and change how much oxalate is passed in urine, which might help prevent kidney stones when following specific diets.

What are the potential side effects?

Since O. formigenes is considered harmless, significant side effects are not expected; however, changes in diet may cause digestive discomfort or alterations in bowel habits.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have liver, kidney, bowel, or hormone diseases affecting drug processing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ stool collected 48-96 hours post diet

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~stool collected 48-96 hours post diet

This trial's timeline: 3 weeks for screening, Varies for treatment, and stool collected 48-96 hours post diet for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of urinary oxalate by ion chromatography mass spectrometry

Secondary study objectives

Measurement of stool oxalate by ion chromatography mass spectrometry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Oxalobacter formigenesExperimental Treatment1 Intervention

Subjects will ingest a live preparation of O.formigenes

Group II: Moderately high oxalate/low calcium dietExperimental Treatment1 Intervention

Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate diet to enhance dietary oxalate absorption. Subjects will be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.

Group III: Low Oxalate DietExperimental Treatment1 Intervention

Subjects not colonized with Oxalobacter formigenes will be equilibrated to a low oxalate diet to determine baseline oxalate values in urine . Subjects will be colonized with Oxalobacter formigenes (Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,648 Previous Clinical Trials

2,344,502 Total Patients Enrolled

14 Trials studying Kidney Stones

778 Patients Enrolled for Kidney Stones

John Knight, PhD4.614 ReviewsPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

1 Previous Clinical Trials

136 Total Patients Enrolled

1 Trials studying Kidney Stones

136 Patients Enrolled for Kidney Stones

5Patient Review

Dr. Knight was very thorough in his explanation of the hip replacement procedure I was considering. He was transparent about what to expect and I'm happy to say that everything went as he said it would. I would recommend him to anyone seeking an orthopaedic surgeon.