A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
研究概览
简要总结
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
详细描述
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Signed informed consent by patient
- •Male or female patients age 18 and older.
- •Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine
排除标准
- •Refusal by patient to sign informed consent form
- •Treatment with antibiotics within 2 weeks prior to screening
- •Treatment with probiotics within 6 weeks prior to screening
- •History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- •Postoperative stoma, ostomy, or ileoanal pouch
- •Participation in any experimental drug protocol within the past 12 weeks
- •Treatment with total parenteral nutrition
- •Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- •Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
结局指标
主要结局
Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
时间窗: 1 year
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
次要结局
- Validation of Sequencing Methods(1 year)