Gluten Free Diet for GVHD Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples
研究概览
简要总结
This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.
详细描述
PRIMARY OBJECTIVES:
I. To determine the rate and severity of gastrointestinal (GI) graft versus host disease (GVHD) in patients assigned to, and compliant with, a gluten free diet (GFD) during initial transplant hospitalization.
SECONDARY OBJECTIVES:
I. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).
OUTLINE:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing an allo-SCT
- •No history of celiac disease or non-celiac gluten sensitivity
- •Male and female and all ethnic groups are eligible
排除标准
- •Pregnant women
- •Children are not eligible as the transplant program is certified as an adult only transplant program
结局指标
主要结局
Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples
时间窗: Up to 12 months post allo-SCT
To determine what the severity is if graft-versus host disease develops.
Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples
时间窗: Up to 12 months post allo-SCT
To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant
Rate of compliance with GFD
时间窗: Up to 30 days
Adherence to diet will be recorded in a food diary. Compliance will be defined as \> 67% of meals being gluten free.
次要结局
未报告次要终点
研究者
Roger Strair, MD, PhD
Associate Professor
Rutgers Cancer Institute of New Jersey