PURE-LC - Probiotic Use for Recovery Enhancement From Long COVID
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Difference in Long COVID Severity
研究概览
简要总结
The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID.
详细描述
The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID. The main questions it aims to answer are:
- Do probiotics reduce the number and severity of symptoms in those with Long COVID?
- Do probiotics improve the physical and mental health quality of life in those with Long COVID?
- Do probiotics improve return to work and daily activities in those with Long COVID?
Researchers will compare probiotics to a placebo (a look-alike substance that contains no probiotics) to see if probiotics work to treat Long COVID.
Participants will take the study medication (placebo or probiotic) for 4 months. They will then cross over (take the other medication) for an additional 4 months. Participants will complete a survey at baseline, 4 months, and 8 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥18 years who report Long COVID with persistent symptoms at the time of study initiation
排除标准
- •No longer have symptoms consistent with LC
- •Are unable to take the study medication daily
- •Are currently pregnant or planning to become pregnant over the course of the study
- •Are currently breastfeeding
- •Have been diagnosed with an immune-compromising condition
- •Are currently taking immunosuppressants
- •Do not speak English as a primary language
- •Are regularly taking probiotics
- •Are enrolled in another Long COVID study with an intervention
研究组 & 干预措施
Probiotic Arm
Probiotic pill taken once daily
干预措施: Probiotic Agent (Drug)
Placebo Arm
Identical placebo pill taken once daily
干预措施: Placebo (Other)
结局指标
主要结局
Difference in Long COVID Severity
时间窗: Baseline, Four, and Eight Months
Defined as the percentage change from moderate-to-severe Long COVID to mild Long COVID using the Long COVID Symptoms and Severity Score (LC-SSS) tool between groups with subgroup analysis by Long COVID trajectory
次要结局
- Difference in LC-SSS Total Score(Baseline, Four, and Eight Months)
- Difference in Quality of Life(Baseline, Four, and Eight Months)
- Difference in Return to Work and Activity(Baseline, Four, and Eight Months)
研究者
Michael Gottlieb
Professor of Emergency Medicine, Vice Chair of Research
Rush University Medical Center