Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Changes in microbiome
研究概览
简要总结
In this prospective study, the primary objective will be to investigate the association between the use of antibiotics administered during the admission period of Stem cell transplant (SCT) and the rate of overall change in microbiota composition across adjacent samples in time.
详细描述
Early preclinical studies suggested that intestinal microflora contribute to aGVHD and may be relapse. There is increasing evidence that use of antibiotics may have a detrimental impact on intestinal microbiota composition and, consequently, the outcome of SCT.However, effect on different antibiotic prophylaxis regimens and broad-spectrum antibiotics used during transplant and the intestinal microbiota composition and hence adverse outcomes are not known. Stool samples will be collected from patients who are undergoing SCT at:
- preconditioning
- at day 0 (stem cell infusion)
- once in the period of day + 7-10 post SCT
- once first day or second day of BMT OPD clinic visit
- once if they develop >=grade I GVHD
- once at time of recovery from GVHD
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure
排除标准
- 未提供
结局指标
主要结局
Changes in microbiome
时间窗: Up to 6 months post stem cell transplant
次要结局
未报告次要终点
研究者
Shatha Farhan
Clinical Assistant Professor
Henry Ford Health System