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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up stool collected 48-96 hours post diet

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of urinary oxalate by ion chromatography mass spectrometry

Secondary outcome measures

Measurement of stool oxalate by ion chromatography mass spectrometry

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,584 Previous Clinical Trials

2,280,050 Total Patients Enrolled

15 Trials studying Kidney Stones

835 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.

Media Library

Oxalobacter formigenes (Bacterium) Clinical Trial Eligibility Overview. Trial Name: NCT03752684 — N/A

Kidney Stones Research Study Groups: Low Oxalate Diet, Moderately high oxalate/low calcium diet, Oxalobacter formigenes

Kidney Stones Clinical Trial 2023: Oxalobacter formigenes Highlights & Side Effects. Trial Name: NCT03752684 — N/A

Oxalobacter formigenes (Bacterium) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03752684 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults of all ages join this clinical trial?

"According to the guidelines for who can participate in this research, the age limit is 65 and the minimum age is 19."

Answered by AI

Are patients currently able to sign up for this treatment program?

"Yes, this information is accurate according to the latest update on clinicaltrials.gov. The study in question was posted on April 2nd, 2018 and was updated as recently as August 17th, 2022."

Answered by AI

For which patient population is this clinical trial designed?

"20 individuals suffering from urolithiasis, aged 19 to 65, who meet the following health criteria are eligible for this clinical trial: lack of O. formigenes colonization and good health as reflected by medical history and current medications."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

John Knight 2018. "Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03752684.