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
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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 19 years.
2. 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
3. Written informed consent
Exclusion Criteria:
1. Pregnant or lactating females
2. Pharmacological therapy for stone disease over the last moth (aside from an increase in water intake)
3. Antibiotic use in the last 3 months prior to the start of study procedures (start of baseline period)
4. 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)
5. Chronic intestinal diseases, or bowel resection surgeries
6. Inability to provide informed consent
Primary outcome measure(s)
Changes in Tributytin Levels — 28 Days change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Trial sites (1)
Facility
City
Region
Status
Vancouver General Hospital
Vancouver
British Columbia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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