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

NCT07004257 | Not Yet Recruiting

• 1 other identifier: H25-00547
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urolithiasis

Keywords

Urolithiasis; Kidney Stones; Urinary Caliculi

Outcome Measures

Primary Outcomes (1)

• Changes in Tributytin Levels

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

  28 Days

Study Arms (1)

tributyrin

EXPERIMENTAL

tributyrin (875 mg, BID)

Dietary Supplement: tributyrin

Interventions

tributyrin DIETARY_SUPPLEMENT

tributyrin (875 mg, BID)

tributyrin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah Hanstock, PhD. Candidate

CONTACT

604-875-4111; shanstock@prostatecentre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)