NCT05951153撤回早期 1 期
Phase I, Single-arm, Dose-escalation Trial of Tributyrin to Promote Gut Health Among Children Undergoing Hematopoietic Cell Transplantation
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Maximum tolerated dose (MTD) of tributyrin among children undergoing hematopoietic cell transplantation (HCT)
研究概览
简要总结
To determine the safety and tolerability of tributyrin among children undergoing hematopoietic cell transplantation (HCT).
详细描述
Primary Objectives:
- Evaluate the safety and tolerability of tributyrin and determine the maximum tolerated dose MTD among children undergoing hematopoietic cell transplantation (HCT).
Secondary Objectives:
- Determine the effect of tributyrin administration on fecal butyrate concentrations.
- Measure the effect of tributyrin on gut microbiome composition and measures of gut inflammation and barrier integrity.
Hypotheses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-17 years with standard of care nasogastric tube placement or existing gastric tubes
- •Planned allogeneic hematopoietic cell transplantation with myeloablative preparative regimen
- •Planned graft-versus-host-disease prophylaxis with calcineurin inhibitor + mycophenoalte mofetil or calcineurin inhibitor + methotrexate
排除标准
- •Previous history of hematopoietic cell transplantataion
结局指标
主要结局
Maximum tolerated dose (MTD) of tributyrin among children undergoing hematopoietic cell transplantation (HCT)
时间窗: 36 months
An evaluation of the safety and tolerability of tributyrin.
次要结局
- Change in gut microbiome composition(Baseline, 36 months)
- Change in fecal butyrate concentration(Baseline, 36 months)
- Change in gut inflammation(Baseline, 36 months)
- Change in gut barrier integrity(Baseline, 36 months)
研究者
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