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

ConditionUrolithiasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • tributyrin

    Dietary supplement

    tributyrin (875 mg, BID)

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: tributyrinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Tributytin Levels

change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.

Time frame
28 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: