About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
tributyrin
Dietary supplementtributyrin (875 mg, BID)
Treatment groups
Trial outcomes
Primary outcomes
Changes in Tributytin Levels
change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: