NCT06013072已完成不适用
The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome: a Placebo-controlled Randomized Clinical Trial
University of Novi Sad, Faculty of Sport and Physical Education2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 years
- •Covid-19 positive test within last 3 months (as documented byvalid PCR or antigentest
- •Moderate-to-severe fatigue (20-MFI test total score > 43.5)
- •At least one of additional covid-19 related symptoms (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties concentrating etc.)
排除标准
- •Other pulmonary and cardiovascular conditions
- •History of dietary supplement use during the past 4 weeks
- •Organic gastrointestinal (GI) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
- •Bowel surgery or short bowel syndrome.
- •Medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months
- •Probiotic or prebiotic supplements in the last 4 weeks
结局指标
主要结局
Fatigue
时间窗: Change from baseline fatigue at 3 months
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
次要结局
- Brain creatine(Change from baseline brain creatine concentrations at 3 months)
- Time to exhaustion(Change from baseline time to exhaustion at 3 months)
- Patient-reported symptoms(Change from baseline fatigue at 3 months)
研究者
Sergej Ostojic
Professor
University of Novi Sad, Faculty of Sport and Physical Education
研究点 (2)
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