Biomarkers for Intestinal Permeability in Patients With Functional Lower Gastrointestinal Disorders Associated With Constipation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Lactulose:C13 Mannitol Excretion Ratio 8-24hrs.
研究概览
简要总结
Our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).
详细描述
In order to determine the differences in permeability in IBS-C in comparison with healthy volunteers, the following will be determined: differences in in vivo small intestinal and colonic permeability, differences in small intestinal and colonic mucosal barrier function, differences in effects of fecal supernatants on barrier function of T84 monolayers, and differences in novel biomarkers for intestinal permeability
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Lactulose:C13 Mannitol Excretion Ratio 8-24hrs.
时间窗: 8-24 hr post test-dose administration
In vivo measurement of intestinal permeability using 13C mannitol \& lactulose was used. High performance liquid chromatography-tandem mass spectrometry was used to measure concentrations calculated using the overall urine volume excreted in each interval. Concentrations of 13C adjusted for the % of 13C in 12C mannitol (4.98% of 12C mannitol excreted was subtracted from 13C mannitol values; determined by analyzing replicate samples of control urine). All lactulose or 13C mannitol concentrations 8-24hr post-ingestion were used to determine colonic permeability. Lactulose to 13C mannitol excretion ratios, as a measure of dose of saccharide administered, were calculated.
次要结局
- Baseline Transmucosal Resistance (TMR) of Duodenal Mucosa(Baseline)
- Baseline Transmucosal Resistance (TMR) of Colonic Mucosa(Baseline)
- Duodenal Impedance(Baseline)
- Lactose:C13 Mannitol Excretion Ratio 0-2hours(0-2 hr post-test dose administration)
- Cumulative FITC-Dextran (4kDa) Concentration Across Colonic Mucosa(3 hours post FITC-Dextran (4kDa) administration)
- Cumulative E.Coli Bio- Particle K12 Concentration Across Colonic Mucosa(3 hours post E.coli Bio- Particle administration)
- Mean Serum Endotoxin (Bacterial LPS) Levels(Fasting, one time measurement after 8 hours)
- Cumulative FITC-Dextran (4kDa) Concentration Across Duodenal Mucosa(3 hours post FITC-Dextran (4kDa) administration)
- Rate of FITC-Dextran (4kDa) Flux Across Duodenal Mucosa(Over 3 hours post FITC-Dextran (4kDa) administration)
- Rate of E.Coli Bio- Particle K12 Flux Across Duodenal Mucosa(Over 3 hours post E.coli Bio- Particle administration)
- Rate of FITC-Dextran (4kDa) Flux Across Colonic Mucosa(Over 3 hours post FITC-Dextran (4kDa) administration)
- Cumulative E.Coli Bio- Particle K12 Concentration Across Duodenal Mucosa(3 hours post E.coli Bio- Particle administration)
- Rate of E.Coli Bio- Particle K12 Flux Across Colonic Mucosa(Over 3 hours post E.coli Bio- Particle administration)
研究者
Madhusudan (Madhu) Grover, MBBS
Principal Investigator
Mayo Clinic