Tributyrin for Kidney Stones

(ButOx Trial)

SH
Overseen BySarah Hanstock, PhD. Candidate
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tributyrin, a supplement that boosts certain gut substances, can help prevent or treat kidney stones. Kidney stones are hard deposits that form in the kidneys, and individuals with this condition often have different gut bacteria compared to healthy individuals. The trial will test if taking tributyrin can reduce stone formation. Ideal candidates are those who have had a kidney stone composed mostly of calcium in the last three years. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new prevention strategies for kidney stones.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have used antibiotics in the last 3 months or taken medication for kidney stones in the last month.

What prior data suggests that tributyrin is safe for humans?

Research has shown that tributyrin is being investigated for its potential to reduce kidney stones. Although no direct studies have assessed its safety for this specific use, tributyrin has been tested in other contexts. For instance, it was included in a supplement mix in a study on memory support, but the study did not focus on the safety of tributyrin alone.

This trial is in the "Not Applicable" phase, indicating that specific safety information for kidney stones is still being collected. Tributyrin is not FDA-approved for any condition, so detailed safety information for humans may be limited. Participants should consider this when deciding to join the trial. Consulting a healthcare provider about any concerns is always advisable.12345

Why are researchers excited about this trial?

Unlike the standard treatments for kidney stones, which often include pain relievers, medical expulsive therapy, or surgical interventions, tributyrin offers a fresh approach. Researchers are excited about tributyrin because it is derived from butyrate, a compound naturally produced in the gut, which may help reduce inflammation and potentially prevent stone formation. Additionally, tributyrin is taken orally, making it a non-invasive option. This unique mechanism and delivery method could offer a simpler and more holistic alternative to current treatments, which are often more invasive or focus on symptom management rather than prevention.

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

Research has shown that tributyrin, the treatment under study in this trial, might help reduce kidney stones. In animal studies, tributyrin significantly lowered crystal deposits in the kidneys, suggesting it could prevent or reduce kidney stone formation. This supplement increases certain substances called short-chain fatty acids (SCFAs), which are usually lower in people with kidney stones. These SCFAs are believed to help prevent stones from forming. Although information from human studies is limited, the results in animals are promising.12678

Are You a Good Fit for This Trial?

This trial is for individuals with kidney stone disease, specifically those with calcium oxalate or struvite stones. Participants should have a history of these types of kidney stones to qualify.

Inclusion Criteria

I am 19 years old or older.
I was diagnosed with a mostly calcium kidney stone in the last 3 years.
Written informed consent

Exclusion Criteria

Inability to provide informed consent
I have not taken antibiotics in the last 3 months.
Pregnant or lactating females
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tributyrin supplementation (875 mg, BID) to assess its effect on markers of calcium oxalate nephrolithiasis

4 weeks
Weekly visits (in-person) for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tributyrin
Trial Overview The study is testing tributyrin supplementation's effect on preventing or treating kidney stones. Tributyrin may increase beneficial gut bacteria byproducts that could reduce stone formation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: tributyrinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Citations

Study Details | NCT07004257 | ButOx Human Trial: An ...Experiments in our lab indicate that tributyrin significantly reduces kidney crystal deposits in a murine model of kidney stone disease.
Tributyrin for Kidney Stones (ButOx Trial)Our data from animal studies indicate that tributyrin supplementation may be able to reduce kidney stone formation. This pilot clinical trial will test if ...
MP63-07 THE BUTOX STUDY: THE ROLE OF THE GUT ...Supplementation of tributyrin in animals fed a high Ox diet resulted in a significant decrease in CaOx crystal formation versus animals on the ...
Vancouver Coastal Research Institute ArchivesOur data from animal studies indicate that tributyrin supplementation may be able to reduce kidney stone formation. This project aims to understand if ...
Beneficial Effects of Butyrate on Kidney Disease - PMCThe results indicate that butyrate alleviated renal injury, kidney oxidative stress, and mitochondrial abnormalities. The authors also found ...
How gut microbiome correlates with oxalate, butyrate and ...Results: Results indicated that the sodium oxalate diet reduced the overall mice microbial alpha diversity and the variability of bacterial groups responsible ...
A Clinical Trial Investigating the Efficacy and Safety of ...The goal of this clinical trial is to investigate the efficacy and safety of Lipase Thera-blend and Lipase Thera-blend + tributyrin on memory in healthy ...
Urolithiasis (DBCOND0032691)Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones ... Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones ...
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