A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease
研究概览
简要总结
The objectives of the study are to evaluate the safety and tolerability of oral administration of MB-102, and to evaluate the use of MB-102 as a means of measuring gut permeability in normal participants (n=10) and in those with radiologic evidence of small bowel Crohn's disease (n=10).
详细描述
This study is a single center, randomized, open label, cross-over study evaluating MB-102 versus dual sugar testing using lactulose and rhamnose for the assessment of gut permeability. Participants will be screened within 30 days of Day 1, and eligible participants will be randomized to receive either an oral dose of MB-102 or the dual sugar test on Day 1. At a second study visit occurring between 3 to 7 days after completion of the first test, participants will return to the study center for the second test. Following completion of the second test, participants will return to the study center 7 ±3 days for a follow-up visit to evaluate safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lactulose/Rhamnose
1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution
干预措施: Lactulose/Rhamnose solution (Drug)
MB-102
4 μmol of MB-102/kg body weight administered orally as a solution
干预措施: MB-102 (Drug)
结局指标
主要结局
Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease
时间窗: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
Urine samples will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after oral administration of MB-102. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods.
次要结局
- Correlation between MB-102 excretion and the results of dual sugar testing in normal participants and in those with Crohn's disease(Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours)