跳至主要内容
临床试验/NCT02940093
NCT02940093Unknown不适用

Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.

研究概览

简要总结

The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient (stem cell recipient) with hematological malignancies, age 3-18
  • Healthy allogeneic stem cell donor (identical or non-identical related donor)

排除标准

  • Patients <3 years of age
  • Patient who are unable to provide urine, stool or blood samples due to their medical condition

结局指标

主要结局

Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.

时间窗: through study completion, anticipated after 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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