Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety as indicated by the lack of infection attributable to probiotic organisms
研究概览
简要总结
RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in patients with suppressed immune systems.
PURPOSE: This phase I trial is studying the side effects and how well giving enteral nutrition, including Lactobacillus, works in preventing infections in patients undergoing donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.
详细描述
OBJECTIVES:
- To determine if patients who are treated with a probiotic-containing diet develop infection with one of the probiotic microorganisms while undergoing allogenic hematopoietic stem cell transplantation for a hematologic malignancy or myelodysplastic syndrome.
OUTLINE: Patients receive oral Lactobacillus rhamosus GG (Culturelle DS) once daily beginning when blood counts have recovered without filgrastim (G-CSF) or sargramostim (GM-CSF) support for 3 consecutive days and continuing for 1 year after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome
- •Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count > 1000/μL for > 3 days without filgrastim (G-CSF) support within 30 days of transplant
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Serum creatinine ≤ 2.0
- •AST or ALT ≤ 3 times upper limit of normal (ULN)
- •Total bilirubin ≤ 2.0 times ULN
- •No clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
- •Able to take medications by mouth
- •No evidence of graft-vs-host disease
- •No history of inflammatory bowel disease or other chronic diarrheal illness
- •No history of hypersensitivity to milk proteins
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
- •No concurrent over-the-counter medications or herbal remedies
排除标准
- 未提供
研究组 & 干预措施
Lactobacillus GG
Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation.
干预措施: Lactobacillus rhamnosus GG (Dietary Supplement)
结局指标
主要结局
Safety as indicated by the lack of infection attributable to probiotic organisms
时间窗: 3 years
次要结局
未报告次要终点