Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT07004257
Brief Summary:
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.
Detailed Description:
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:
1. Investigate tributyrin supplementation to increase butyrate levels (stool, blood) in a population with a history of calcium oxalate nephrolithiasis
2. Understand how tributyrin supplementation influences measures related to stone formation
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:
1. Changes in urine oxalate levels
2. Changes in stool oxalate levels
3. Changes in stool butyrate levels
4. Changes in urinary chemical levels (citrate, calcium, phosphate, uric acid, creatinine, and pH)
5. Changes in urinary inflammatory markers (IL-6, IL-8, IL-10, and IL-18)
6. Changes in urinary markers of oxidative stress (8-OHdG)
7. Changes in microbiome composition
8. Measurement of nutrient intake using ASA24® dietary assessment tool (oxalate, calcium, dietary fibre, and water intake)
9. Measurement of crystalluria
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.
Study:
NCT07004257
Study Brief:
Protocol Section:
NCT07004257