Oxalobacter Formigenes for Kidney Stones

Overseen By Demond Wiley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Hepatic, renal, bowel, endocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Oxalobacter formigenes for kidney stones?

Research suggests that Oxalobacter formigenes, a type of bacteria in the gut, can help reduce the risk of kidney stones by breaking down oxalate, a key component of most kidney stones. Studies in animals and humans show that having this bacteria in the gut is linked to lower levels of oxalate in urine, which may help prevent kidney stones. ^{1 2 3 4 5}

Is Oxalobacter formigenes safe for humans?

Oxalobacter formigenes is a type of bacteria that naturally lives in the human gut and helps break down oxalate, which can form kidney stones. It has been studied in healthy volunteers and patients with kidney stone conditions, suggesting it is generally safe for human use. ^{1 2 5 6 7}

How does the treatment Oxalobacter formigenes work for kidney stones?

Oxalobacter formigenes is a unique treatment because it is a type of bacteria that lives in the gut and breaks down oxalate, a substance that can form kidney stones. Unlike other treatments, it works by reducing the amount of oxalate that gets into the urine, potentially lowering the risk of stone formation. ^{1 3 5 6 7}

Research Team

John Knight

Principal Investigator

University of Alabama at Birmingham

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Control

Participants follow a controlled diet to establish baseline oxalate values and prepare for colonization

1 week per diet phase with a 1-week washout

Multiple visits for dietary monitoring and urine collection

Colonization and Monitoring

Participants are colonized with Oxalobacter formigenes and monitored for changes in urinary oxalate

4 weeks

Regular visits for monitoring and sample collection

Follow-up

Participants are monitored for sustainability of colonization and changes in oxalate excretion

4 weeks

Treatment Details

Interventions

• Oxalobacter formigenes

Trial Overview 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.

Participant Groups

Group I: Oxalobacter formigenes Experimental Treatment 1 Intervention

Subjects will ingest a live preparation of O.formigenes

Group II: Moderately high oxalate/low calcium diet Experimental Treatment 1 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 Diet Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Transplanting human feces along with the O. formigenes strain into mice successfully established stable colonization of these bacteria for at least 8 weeks, indicating a potential model for studying their effects on kidney stone risk.

The humanization process significantly altered the gut microbiome of the mice, suggesting that O. formigenes can integrate into and modify the intestinal microbial community, which may help in identifying effective strains for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Humanized Murine Model for the Study of Oxalobacter formigenes Intestinal Colonization. Pebenito, AM., Liu, M., Nazzal, L., et al.[2020]

The presence of the bacterium Oxalobacter formigenes in the intestine can help reduce urinary oxalate levels, which lowers the risk of developing calcium oxalate kidney stones.

The genome sequence of a specific strain, Oxalobacter formigenes SSYG-15, was obtained from a healthy individual, providing valuable genetic information that could enhance our understanding of its beneficial effects on kidney stone prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome Sequence of Oxalobacter formigenes Strain SSYG-15. Sun, NY., Gao, Y., Yu, HJ.[2020]

In a study using male Sprague-Dawley rats with induced hyperoxaluria, treatment with the bacterium Oxalobacter formigenes significantly reduced urinary oxalate levels within just 2 days, with greater reductions observed at higher doses.

The probiotic treatment was found to be safe, as the rats showed no signs of toxicity or health issues, suggesting that O. formigenes could be a promising option for managing calcium oxalate kidney stone disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid reversal of hyperoxaluria in a rat model after probiotic administration of Oxalobacter formigenes. Sidhu, H., Allison, MJ., Chow, JM., et al.[2017]

Oxalobacter formigenes, a gut bacterium, helps break down oxalate, which can lower urinary oxalate levels and potentially reduce the risk of kidney stones, particularly those made of calcium oxalate.

The review highlights the impact of antibiotics on the colonization of Oxalobacter formigenes and suggests that probiotics and whole microbial communities could be explored as possible treatments for kidney stone disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the microbiome in kidney stone formation. Mehta, M., Goldfarb, DS., Nazzal, L.[2018]

In a study of 76 children and adolescents with calcium oxalate urolithiasis, only 27.6% were colonized with the bacterium Oxalobacter formigenes, similar to the 26% colonization rate in healthy controls.

Children with calcium urolithiasis who were colonized with O. formigenes had significantly lower urinary oxalate excretion compared to those who were not colonized, suggesting that the absence of this bacterium may contribute to higher oxalate levels and increased risk of kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal colonization with Oxalobacter formigenes and its relation to urinary oxalate excretion in pediatric patients with idiopathic calcium urolithiasis. Sikora, P., Niedźwiadek, J., Mazur, E., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a Humanized Murine Model for the Study of Oxalobacter formigenes Intestinal Colonization. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Genome Sequence of Oxalobacter formigenes Strain SSYG-15. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Rapid reversal of hyperoxaluria in a rat model after probiotic administration of Oxalobacter formigenes. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Direct correlation between hyperoxaluria/oxalate stone disease and the absence of the gastrointestinal tract-dwelling bacterium Oxalobacter formigenes: possible prevention by gut recolonization or enzyme replacement therapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The role of the microbiome in kidney stone formation. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Intestinal colonization with Oxalobacter formigenes and its relation to urinary oxalate excretion in pediatric patients with idiopathic calcium urolithiasis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Forty Years of Oxalobacter formigenes, a Gutsy Oxalate-Degrading Specialist. [2022]