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Bacteria Therapy

colonization with Oxalobacter formigenes 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

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

Primary outcome measures

Change in urinary oxalate excretion following colonization with Oxalobacter formigenes

Secondary outcome measures

Sustainability of colonization with Oxalobacter formigenes

Trial Design

1Treatment groups

Experimental Treatment

Group I: colonization with Oxalobacter formigenesExperimental Treatment5 Interventions

Colonization with a live preparation of Oxalobacter formigenes, strain OxCC13.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,622 Total Patients Enrolled

14 Trials studying Kidney Stones

795 Patients Enrolled for Kidney Stones

University of Texas Southwestern Medical CenterOTHER

1,048 Previous Clinical Trials

1,053,695 Total Patients Enrolled

4 Trials studying Kidney Stones

612 Patients Enrolled for Kidney Stones

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

2,359 Previous Clinical Trials

4,314,552 Total Patients Enrolled

5 Trials studying Kidney Stones

550 Patients Enrolled for Kidney Stones

Frequently Asked Questions

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

Are there any current opportunities for potential participants to enroll in this trial?

"Indeed, the details on clinicaltrials.gov indicate that this particular clinical trial is actively seeking individuals to participate. The trial was initially uploaded on April 1st, 2024 and underwent its most recent revision on March 19th, 2024. Enrollment for this study aims to reach a total of 40 participants spread across two distinct sites."

Answered by AI

Is the eligibility criteria for this research study restricted to individuals younger than 80 years of age?

"Participants aged over 18 and under 70 are eligible for this research."

Answered by AI

What is the overall count of individuals partaking in this medical study?

"Affirmative. Data on clinicaltrials.gov confirms that this medical investigation is presently seeking individuals to partake. Initially shared on April 1st, 2024, the most recent update was on March 19th, 2024. A total of 40 participants are sought from two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Sonia Fargue 2024. "O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06330246.

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