UrolithiasisButOxNCT07004257
ButOx Human Trial: An Open Label Prospective Cohort Study to Investigate the Effect of Tributyrin (Butyrate Precursor Molecule) Supplementation on Markers of Calcium Oxalate Nephrolithiasis
A study testing tributyrin in people with Urolithiasis, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- tributyrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- History of nephrolithiasis, diagnosed with a kidney stone containing >80% calcium (from stone analysis of spontaneously passed or surgically removed kidney stone) within the past 3 years
- Written informed consent
Who cannot join
- Pregnant or lactating females
- Pharmacological therapy for stone disease over the last moth (aside from an increase in water intake)
- Antibiotic use in the last 3 months prior to the start of study procedures (start of baseline period)
- Subjects with comorbid conditions which may influence the microbiome or increase the risk of nephrolithiasis (inflammatory bowel diseases, bariatric surgery, active malignancy, celiac disease, cystic fibrosis, diabetes mellitus, urinary tract obstruction, renal tubular acidosis)
- Chronic intestinal diseases, or bowel resection surgeries
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Victor Clinical Research Manager, 6048754111 ext. 62421, victor.kf.wong@ubc.ca
Ben Chew, MD
About this study
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.
Read the 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:
- Investigate tributyrin supplementation to increase butyrate levels (stool, blood) in a population with a history of calcium oxalate nephrolithiasis
- 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:
- Changes in urine oxalate levels
- Changes in stool oxalate levels
- Changes in stool butyrate levels
- Changes in urinary chemical levels (citrate, calcium, phosphate, uric acid, creatinine, and pH)
- Changes in urinary inflammatory markers (IL-6, IL-8, IL-10, and IL-18)
- Changes in urinary markers of oxidative stress (8-OHdG)
- Changes in microbiome composition
- Measurement of nutrient intake using ASA24® dietary assessment tool (oxalate, calcium, dietary fibre, and water intake)
- 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.
- Conditions
- Urolithiasis
- Being tested
- tributyrin
- Keywords
- Urolithiasis, Kidney Stones, Urinary Caliculi
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tributyrinDietary supplement
tributyrin (875 mg, BID)
| Study group | Role | What they receive |
|---|---|---|
| tributyrin | Experimental | tributyrin (875 mg, BID) Receives: Dietary Supplement: tributyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tributytin Levels
change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004257
- Sponsor's protocol ID
- H25-00547
- Acronym
- ButOx
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ButOx Human Trial: An Open Label Prospective Cohort Study to Investigate the Effect of Tributyrin (Butyrate Precursor Molecule) Supplementation on Markers of Calcium Oxalate Nephrolithiasis
- ClinicalTrials.gov ID
- NCT07004257
- Acronym / sponsor ID
- ButOx / H25-00547
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, Kidney Stones, Urinary Caliculi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate tributyrin supplementation to increase butyrate levels (stool, blood) in a population with a history of calcium oxalate nephrolithiasis
- 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:
- Changes in urine oxalate levels
- Changes in stool oxalate levels
- Changes in stool butyrate levels
- Changes in urinary chemical levels (citrate, calcium, phosphate, uric acid, creatinine, and pH)
- Changes in urinary inflammatory markers (IL-6, IL-8, IL-10, and IL-18)
- Changes in urinary markers of oxidative stress (8-OHdG)
- Changes in microbiome composition
- Measurement of nutrient intake using ASA24® dietary assessment tool (oxalate, calcium, dietary fibre, and water intake)
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tributyrin | Experimental | Dietary Supplement: tributyrintributyrin (875 mg, BID) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19 years.
- History of nephrolithiasis, diagnosed with a kidney stone containing >80% calcium (from stone analysis of spontaneously passed or surgically removed kidney stone) within the past 3 years
- Written informed consent
Key exclusion criteria (6 listed)
- Pregnant or lactating females
- Pharmacological therapy for stone disease over the last moth (aside from an increase in water intake)
- Antibiotic use in the last 3 months prior to the start of study procedures (start of baseline period)
- Subjects with comorbid conditions which may influence the microbiome or increase the risk of nephrolithiasis (inflammatory bowel diseases, bariatric surgery, active malignancy, celiac disease, cystic fibrosis, diabetes mellitus, urinary tract obstruction, renal tubular acidosis)
- Chronic intestinal diseases, or bowel resection surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tributyrintributyrin (875 mg, BID) | Dietary supplement | tributyrin |
Primary outcome
Changes in Tributytin Levels
Time frame: 28 Days
change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tributyrin in people with Urolithiasis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hanstock, PhD. Candidate (604-875-4111 ext. 62421, shanstock@prostatecentre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Tributytin Levels (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.