Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- quality of iNKT reconstitution after HSCT (good/poor)
研究概览
简要总结
Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).
详细描述
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the major curative therapeutic approach for hematologic neoplasms. After HSCT, patients have a compromised GI mucosal barrier and an altered microbiota, also called dysbiosis. The later could be due to conditioning or use of broad-spectrum antibiotics, and could be accentuate by stress encountered by patients during their therapy management. Recent data have shown that alterations in the intestinal flora are associated with bad outcome, particularly with graft-versus-host disease (GVHD), bacteremia, and reduced overall survival post-transplantation. How intestinal bacteria can modulate the risk of relapse after HSCT is yet unknown. The scientists hypothesize that the variation of some bacterial taxa may influence post-transplant immune reconstitution, particularly invariant Natural Killer T cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients > 18 years affiliated to a social security system
- •Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor)
- •Graft of peripheral blood stem cell
- •GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.
排除标准
- •HIV+ patients
- •Patients with active HBV or HCV
研究组 & 干预措施
Patient
For all patients included in the study, the following interventions will be performed :
- several blood samples (quantity collected requiring classification of this study as interventional according to French law)
- several fecal samples
- anxiety tests
- stress tests
干预措施: blood samples (Biological)
Patient
For all patients included in the study, the following interventions will be performed :
- several blood samples (quantity collected requiring classification of this study as interventional according to French law)
- several fecal samples
- anxiety tests
- stress tests
干预措施: fecal samples (Biological)
Patient
For all patients included in the study, the following interventions will be performed :
- several blood samples (quantity collected requiring classification of this study as interventional according to French law)
- several fecal samples
- anxiety tests
- stress tests
干预措施: Anxiety test (Behavioral)
Patient
For all patients included in the study, the following interventions will be performed :
- several blood samples (quantity collected requiring classification of this study as interventional according to French law)
- several fecal samples
- anxiety tests
- stress tests
干预措施: Stress test (Behavioral)
结局指标
主要结局
quality of iNKT reconstitution after HSCT (good/poor)
时间窗: Day 90,
次要结局
- GVH disease(Day 30, Day 60, Day 90)
- gut microbiota composition(Day 0, Day 15, Day 30, Day 90)
- immune reconstitution after HSCT (other immune cells)(Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2)
- use of antibiotics(Day 0, Day 15, Day 30, Day 60, Day 90)
- level of stress(Day -8, Day 15, Day 30, Day 90)
- level of anxiety(Day -8, Day 15, Day 30, Day 90)
- quality of iNKT reconstitution after HSCT (good/poor)(Day 15, Day 30, Day 60, Day 180, Year 1, Year2)