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
- 1
- 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
研究组 & 干预措施
Prevention (gluten free diet)
Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.
干预措施: Dietary Intervention (Other)
Prevention (gluten free diet)
Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.
干预措施: Laboratory Biomarker Analysis (Other)
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