NCT04148222撤回不适用
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
ProgenaBiome1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation of Microbiome to Lyme Disease 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 Lyme Disease
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 Lyme Disease
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- •Male or female patients of any age (interest is given to children to compare with mothers)
- •Diagnosis of Lyme Disease
排除标准
- •Refusal to sign informed consent form
- •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 to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
结局指标
主要结局
Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing
时间窗: One 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 categorized among specific disease types.
次要结局
- Validation of Sequencing Methods(One year)
研究者
研究点 (1)
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