Oxalobacter Formigenes for Kidney Stones

Recruiting in Palo Alto (17 mi)

Overseen byJohn Knight

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of human subjects and to determine whether this influences the oxalate passed in urine of healthy volunteers.

Eligibility Criteria

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.

Inclusion Criteria

I am in good health based on my medical history and medications.

You do not have O. formigenes bacteria in your body.

Exclusion Criteria

I carry the O. formigenes bacteria.

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

Your urine or blood tests show abnormal levels of certain chemicals or substances.

Participant Groups

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.

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.