Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
研究概览
简要总结
This cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital Leuven (Campus Gasthuisberg) and University Hospital Gent.
Primary Objective
•To assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (AML) compared to matched control subjects.
Secondary Objectives
- To investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites).
- To characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis.
- To assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis.
Study Design
This is an academic multi-centric prospective study. The study is composed of two cohorts (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. Muscle strength and body composition are also measured. Only patients receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (T1) and at discharge (T4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with
- •A diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML)
- •Acute leukemia's of ambiguous lineage according to WHO 2008
- •A diagnosis of refractory anemia with excess of blasts (MDS REAB) 2 and IPSS (International Prognostic Scoring System)-R score >
- •World Health Organization performance status 0, 1 or 2
- •Sampled bone marrow and/ blood cells at diagnosis with molecular analysis.
- •Written informed consent
- •Good command of the French or Dutch language
排除标准
- •Age < 18 years
- •Age > 75 years
- •Pregnancy
- •Antibiotics consumption during the last 30 days before inclusion
- •Recent chemotherapy (< 3 months), with exclusion of hydroxyurea
- •Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance)
- •Gastric bypass
- •Current treatment with antidiabetic or hypoglycemic drugs
结局指标
主要结局
Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects
时间窗: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
Sequencing DNA extracts from patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to obtain the description of gut microbiota composition in those patients
Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects
时间窗: Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy
1H-NMR metabolomics performed on patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to report the metabolites produced by the gut microbiota of those patients
次要结局
- Changes in body composition(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in appetite(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in muscle strength(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in gut microbiota-related markers in the blood (microbial metabolites)(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)
- Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0(at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);)