Investigation of the Use of a Probiotic Supplement in People With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- FACIT fatigue scale
研究概览
简要总结
This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.
详细描述
240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).
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
- •Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or suspected Covid-19 infection).
排除标准
- •Significant co-morbidities - no pre-existing diagnosis of hypertension, diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or haematological disorder or current or recent cancer.
结局指标
主要结局
FACIT fatigue scale
时间窗: 12 weeks
Measure that assesses self-reported fatigue and its impact upon daily activities and function
Fatigue severity scale (FSS)
时间窗: 12 weeks
9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
时间窗: 12 weeks
Evaluation of ability to participate in social roles and activities
EQ-5D-5L
时间窗: 12 weeks
Multi-attribute generic health status measure
Ecological Momentary Assessment (EMA) app
时间窗: 12 weeks
Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)
次要结局
- MRC Dyspnoea scale(12 weeks)
- Gastrointestinal Symptom Rating Scale(12 weeks)
- IBS-SSS(12 weeks)
- Accelerometery data(12 weeks)
- 16S rRNA sequencing(12 weeks)
- Analysis of inflammatory markers(12 weeks)
- International. Physical Activity Questionnaire (short form)(12 weeks)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(12 weeks)