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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a harmless bacterium, Oxalobacter formigenes, can settle in the gut and influence the amount of oxalate—a natural chemical that can form kidney stones—in the urine of healthy individuals. Researchers aim to determine if the presence of this bacterium can help manage urinary oxalate levels, potentially reducing the risk of kidney stones. The trial seeks participants who are in good health and do not already carry this bacterium. As an unphased trial, it offers a unique opportunity to contribute to scientific understanding and potentially benefit future kidney stone prevention strategies.

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 prior data suggests that Oxalobacter formigenes is safe for human consumption?

Research shows that Oxalobacter formigenes is safe for humans. Studies have found that this bacterium can live in the gut without causing harm and naturally exists in some people's digestive systems. Previous research has shown that it can settle in the gut and lower oxalate levels in urine, reducing the risk of kidney stones. Although specific safety data from these studies is lacking, the use of a naturally occurring bacterium suggests it should be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for kidney stones focus on pain management, stone removal, or reducing stone formation through medication and dietary changes. But Oxalobacter formigenes works differently, targeting the root cause by using a naturally occurring bacterium to break down oxalate in the gut before it can form stones. Researchers are excited about this approach because it could reduce oxalate levels without relying on medications that might have side effects. This method of colonization with beneficial bacteria offers a novel way to address kidney stones at their source, potentially providing a more natural and sustainable solution.

What evidence suggests that Oxalobacter formigenes might be an effective treatment for kidney stones?

Research has shown that Oxalobacter formigenes, a harmless type of bacteria, might help lower the risk of developing kidney stones made of calcium oxalate. One study found that people with this bacterium in their gut had a 70% lower chance of experiencing recurrent kidney stones. Another study demonstrated that the presence of this bacterium in the gut can reduce the risk of kidney stones returning. People who frequently develop kidney stones typically have less of this bacterium compared to those who do not, suggesting that its presence might offer protection against kidney stones. This trial will investigate the effects of colonizing participants with Oxalobacter formigenes to manage the risk of kidney stones. ^{1 2 3 6 7}

Who Is on the Research Team?

John Knight

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Colonization with Oxalobacter formigenes Experimental Treatment 3 Interventions

Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. nature.com nature.com/articles/s41598-018-36670-z

Comparative prevalence of Oxalobacter formigenes in ... Studies comparing adults with recent nephrolithiasis and healthy adults showed a lower rate of O. formigenes colonization in the stone formers, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2396938/

Oxalobacter formigenes May Reduce the Risk of Calcium ... formigenes is associated with a 70% reduction in the risk for being a recurrent calcium oxalate stone former. Kidney stones represent an important health ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925000932

Inducing Oxalobacter formigenes Colonization Reduces ... Kaufman and colleagues also demonstrated that colonization was associated with a reduced risk of developing recurrent calcium oxalate kidney stones. Rodent ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5764756/

The role of the microbiome in kidney stone formation - PMC In this review, we examine the data studying the role of Oxalobacter formigenes in kidney stone disease in humans and animals, the effect of antibiotics on ...

5. kidney-international.org kidney-international.org/article/S0085-2538%2815%2955877-8/fulltext

A new era in the treatment of calcium oxalate stones? In this study, based on stool culture, 17% of the stone formers were found to be positive for O. formigenes vs. 38% of healthy subjects. This association ...

6. withpower.com withpower.com/trial/gut-bacteria-for-kidney-stones-e3f7d

Gut Bacteria for Kidney Stones Is Oxalobacter formigenes safe for humans? The research does not provide specific safety data for Oxalobacter formigenes, but it is a naturally occurring ...

7. nature.com nature.com/articles/ncpneph0812-nrurol

Absence of Oxalobacter formigenes is associated with ... O. formigenes colonization was less prevalent among patients with kidney stones than among controls (17% vs 38%, multivariate odds ratio 0.3, 95% CI 0.2– ...