NCT04835792Unknown不适用
Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease
研究概览
简要总结
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥18 years of age.
- •Able to read, understand, and provide signed informed consent.
- •Willing to provide blood and stool samples.
- •Able to communicate adequately and to comply with the requirements for the entire study.
- •Must be willing to discontinue antibiotics 2 weeks prior to sample collection.
- •If participating in the previously treated Lyme Disease arm, the participants must meet the following criteria: 1) Diagnosis of prior Lyme Disease supported by either an erythema migrans rash (either classic "bull's eye" or irregular) OR a CDC-positive Western blot, 2) previously treated with antibiotics for Lyme Disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for Lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms).
- •If participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a Lyme Disease diagnosis, 2) in generally good health
排除标准
- •Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
结局指标
主要结局
• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease
时间窗: 30 days
• Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease
时间窗: 30 days
• To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease
时间窗: 30 days
• To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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