ButOx Human Trial: An Open Label Prospective Cohort Study to Investigate the Effect of Tributyrin… (NCT07004257) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Canada10 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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