Oxalobacter Formigenes Colonization and Oxalate Excretion in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes
研究概览
简要总结
The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of healthy participants and to determine whether this influences the oxalate passed in urine.
详细描述
Adults that are not colonized with O. formigenes, have no history of stone disease, and are in good health as judged by their medical history and a complete metabolic profile of their serum, will be recruited from within the greater Birmingham area.
Participants not colonized with O. formigenes will consume a controlled diet containing moderately high levels of oxalate (210-240 mg per day), and low levels of calcium (500 - 700 mg per day) and collect 24-hour urines to measure oxalate excretion. Following completion of urine collections, participants will ingest live O.formigenes and one week later stool will be provided to test for colonization with O.formigenes. Participants that are successfully colonized with O.formigenes will then repeat 24 hour urine collections on the same high oxalate, low calcium diet. Controlled diets will be prepared in the Metabolic Kitchen of the UAB Clinical Research Unit (CRU). Sustainability of colonization will be determined over time. Loss of colonization will be confirmed by having the subject consume an oxalate-rich meal with subsequent testing for O. formigenes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health as judged from a medical history and reported medications
- •Not colonized with O. formigenes
排除标准
- •History of any hepatic, renal, bowel or endocrine disease or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results
- •colonized with O. formigenes
- •abnormal urine chemistries or blood metabolic profiles
研究组 & 干预措施
Colonization with Oxalobacter formigenes
Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet
干预措施: Moderately high oxalate/low calcium diet non-colonized (Dietary Supplement)
Colonization with Oxalobacter formigenes
Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet
干预措施: Oxalobacter formigenes (Dietary Supplement)
Colonization with Oxalobacter formigenes
Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet
干预措施: Moderately high oxalate/low calcium diet colonized (Dietary Supplement)
结局指标
主要结局
Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes
时间窗: 4 days
Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization
次要结局
- Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes(4 days)
研究者
John Knight
Associate Professor
University of Alabama at Birmingham