跳至主要内容
临床试验/NCT05186857
NCT05186857进行中(未招募)不适用

Impact of Intestinal Metabolome and Microbiome Disbalance of Recipients of Hematopoietic Transplant in the Development of Acute Graft Versus Host Disease.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla9 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
88
试验地点
9
主要终点
Incidence of Acute graft versus host disease

研究概览

简要总结

Recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-SCT) recipients might influence incidence and severity of acute graft versus host disease (aGVHD). Nevertheless, this possible relationship has not been undoubtedly established, pathophysiologic mechanisms have not been elucidated and possible clinical implications have not been studied. We hypothesized that in the early phase of allo-SCT, specific alterations in faecal metabolome occurred related to loss of intestinal microbiota diversity and disbalance of specific bacterial taxa, and that both alterations determine reduced survival of patients through increased incidence and severity of aGVHD. To test this hypothesis, a prospective multi-center cohort of allo-SCT recipients will had faecal and plasmatic samples collected at predetermined time-points pre&post-allo-SCT, and clinical relevant variables will be prospectively recorded throughout two years posttransplant follow-up. Metabolomic and microbiome analysis will be done to answer objectives of the study. To additionally explore if differential evolving characteristics in the intestinal metabolome and microbiome of donor/recipient sibling pairs influence the incidence and severity of aGVHD, probability of malignancy relapse and early and late mortality an additional cohort of family donors of enrolled patients will also have faecal and plasmatic samples collected and analysed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.
  • Inclusion Criteria:
  • Patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis.
  • Agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable).

排除标准

  • - Allotransplant recipients in stages after the initial pre-conditioning.
  • Family donors from patients included in the study:
  • Inclusion criteria:
  • Agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable).
  • Donor relatives with any degree of identity in the Human Leukocyte Antigens (HLA).
  • Exclusion Criteria:
  • Unrelated donors
  • Transplants from umbilical cord blood source.

结局指标

主要结局

Incidence of Acute graft versus host disease

时间窗: From the day of transplant (Day 0) to Day +100 posttransplant.

Comparison of the incidence of any degree, degree-II and degree-III/IV of acute graft versus host disease between sub-groups of patients defined according to obtained metabolome results.

Disease free survival

时间窗: From the day of transplant (Day 0) to 2 years posttransplant.

Comparison of overall survival between obtained groups according to metabolome results.

Metabolome

时间窗: From pre-Conditioning (Day -15) to Day +100 post-transplant.

Sequential pre-transplant/post-transplant modifications in faecal and plasmatic levels of: 1.a. Butyrate (targeted analysis), 1.b: Biliary acids (targeted analysis) and 1.c. Metabolomic signature (untargeted analysis).

Overall Survival

时间窗: From the day of transplant (Day 0) to 2 years posttransplant.

Comparison of overall survival between obtained groups according to metabolome results.

次要结局

  • Microbiome (alpha diversity of the intestinal microbiota)(At Day -15 and Day +30 post-transplant.)
  • Relapse(From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.)
  • Mortality(From the day of transplant (Day 0) to Days +30, +100, +365 and two years posttransplant.)
  • Microbiome (beta diversity of the intestinal microbiota)(At Day -15 and Day +30 post-transplant.)
  • Microbiome (beta diversity of the plasmatic microbiota)(At Day -15 and Day +30 post-transplant.)
  • Microbiome (alpha diversity of the plasmatic microbiota)(At Day -15 and Day +30 post-transplant.)

研究者

研究点 (9)

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