An interventional study of tributyrin in Urolithiasis, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by University of British Columbia · Not applicable, Interventional, and Other
Kidney stone disease (KSD) is a condition where there are crystal deposits in the kidney. The gut microbiome is a community of gut bacteria which can produce substances such as short chain fatty acids (SCFAs). Individuals with KSD have a different gut microbiome composition and lower amounts of these SCFAs compared to healthy individuals. Tributyrin is a supplement which can increase levels of SCFAs. Our data from animal studies indicate that tributyrin supplementation may be able to reduce kidney stone formation. This pilot clinical trial will test if tributyrin supplementation helps in prevention or treatment of those with KSD.
Purpose
The objective of this pilot study is to understand how the butyrate prodrug, tributyrin (875 mg, BID) influences urine and stool parameters of kidney stone disease.
Hypothesis
The hypothesis of this study is that the tributyrin is able to reduce levels of markers related to stone formation. There has been no study to date which investigates the potential for tributyrin or other butyrate supplements in relationship to these markers of kidney stone disease. Through this pilot study we plan to capture sufficient data in a small group of individuals to understand the clinical implications for tributyrin supplementation.
Justification
While there are a variety of options for treating kidney stones, preventative measures are lacking and largely include a variety of lifestyle changes. A dysbiotic gut microbiome has been implicated in kidney stone disease for the past 20-years, however we have yet to develop effective therapeutics which target the gut microbiome. Experiments in our lab indicate that tributyrin significantly reduces kidney crystal deposits in a murine model of kidney stone disease. As such it is important to understand if tributyrin modulates levels of urine and stool parameters related to kidney stone disease.
Objectives
The objectives of this study are to:
Study Endpoints
The primary endpoint of this study is change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Secondary endpoints include:
Statistical Analysis
For our pilot trial we plan to recruit 10 subjects and use a within-subjects design. Since this is a pilot study, we will use the results for power calculations to understand an appropriate sample size for a larger study. Data collected from the biological samples will be analyzed with the paired-samples t-test. Due to the novelty of this research in humans, we will run covariate analyses on our pilot data to determine which variables may be confounding, but we expect to include variables such as sex, age, number of previous kidney stones, and dietary habits. Microbiome data will be analyzed in our sequencing facility at The Stone Centre. The ASA24® dietary assessment data will be analyzed using the ASA24® Researcher Website and consumption of oxalate, calcium, and hydration status will be used for dietary habit analysis.
If we see a significant elevation (p\<0.05) in serum butyrate levels, accompanied by changes in oxalate excretion (indicated by stool, serum, and urine oxalate levels) and changes in urine biomarkers in individuals taking the tributyrin supplement this trial will be successful, and be continued in follow-up experiments.
253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 182 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tributyrin (875 mg, BID)
Dietary Supplement: tributyrin
tributyrin (875 mg, BID)
Changes in Tributytin Levels
change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Time frame: 28 Days
Plan to share: No
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Studies of the drug tested here: Tributyrin
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