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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Tributytin Levels
研究概览
简要总结
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.
详细描述
Purpose
The objective of this pilot study is to understand how the butyrate prodrug, tributyrin (875 mg, BID) influences urine and stool parameters of kidney stone disease.
Hypothesis
The hypothesis of this study is that the tributyrin is able to reduce levels of markers related to stone formation. There has been no study to date which investigates the potential for tributyrin or other butyrate supplements in relationship to these markers of kidney stone disease. Through this pilot study we plan to capture sufficient data in a small group of individuals to understand the clinical implications for tributyrin supplementation.
Justification
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
tributyrin
tributyrin (875 mg, BID)
干预措施: tributyrin (Dietary Supplement)
结局指标
主要结局
Changes in Tributytin Levels
时间窗: 28 Days
change in serum butyrate levels when comparing baseline (pre-tributyrin) and endpoint (post-tributyrin) levels.
次要结局
未报告次要终点
研究者
Ben Chew, MD
Associate Professor
University of British Columbia